Alerta De Seguridad para CIRCUMCISION CLAMPS: (1) GOMCO, (2) GOMCO-TYPE, (3) MOGEN, (4) MOGEN-TYPE

Safety alert

162

2000-10-27

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

The united states central for devices and radiological health (cdrh) / food and drug administration published a security notification informing hospitals that had received 105 injury reports involving the circumvention reports mentioned between july 1996 and january 2000. the use of gomco and gomco-type graphics which have been returned by users, with parts of other manufacturers, or which have curved parts or malfuncted components, caused the breaking of the clamps, slipping, falling during use, penis tissue ruptures or failure in the lacre. the use of the mogen and mogen-type clamps which have opening dimensions of the arms greater than those specified by the manufacturer and the use of inappropriate sizes may cause patients injury. in these cases, the clip may allow the passage of an excessive quantity of fabric for the opening of the equipment, facilitating therefore the removal of an excessive quantity of preparation and, in some cases, of a piece of the glen of the penis.

CDRH RECOMMENDS HOSPITALS TO EXAMINE YOUR CLIPS TO DETERMINE WHETHER ALL PARTS ARE AVAILABLE, NOT DAMAGED, AND WITHIN THE MANUFACTURER'S SPECIFICATIONS. CDRH / FDA MAKES THE FOLLOWING RECOMMENDATIONS FOR GOMCO AND GOMCO-TYPE CLAMPS: (1) IF YOU CAN NOT CERTIFY THAT THE CLIP IS PART OF AN ORIGINAL CLIP, OR IF THE CLIP HAS LOST TO THE THREAD, BE WITH THE BASE OR THE HARMED ARM, TOOTHED TEETH OR THE DAMAGED RINGER, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH THE MANUFACTURER TO OBTAIN REPLACEMENT PARTS OR DISPOSE THE CLAMP. (2) WHEN REQUESTING REPLACEMENT PARTS, CHECK WITH THE MANUFACTURER OR SUPPLIER, IF THE PARTS REQUESTED ARE COMPATIBLE WITH THE OTHER COMPONENTS OF YOUR EQUIPMENT. DO NOT REPLACE PARTS OF DIFFERENT STAPLER MANUFACTURER. (3) MAKE SURE TO REMOVE THE CLIP ONLY WITH THE OWN PARTS OF THE CLIP. DO NOT MIX DIFFERENT CLAMP PARTS, EVEN IF THEY ARE THE SAME MANUFACTURER UNLESS THE MANUFACTURER HAS ENSURED THAT THE PARTS ARE COMPATIBLE. (4) IF YOU DECIDE TO MARK THE CLAMP PARTS TO ENSURE THE CORRECT REMOVAL OF THESE INSTRUCTIONS, ASK THE FIRST MANUFACTURER BECAUSE SOME METHODS OF BRANDING MAY FACE THE CLAMP OR COMPROMISE YOUR STERILIZATION CAPACITY. CDRH MAKES THE FOLLOWING RECOMMENDATIONS FOR MOGEN AND MOGEN-TYPE CLAMS: (1) MAKE SURE THE USED CLIPS ARE OF SIZE APPROPRIATE TO THE PATIENT. SOME MANUFACTURERS PRODUCE TWO TYPES OF CLIPS, ONE FOR ADULTS AND ONE FOR CHILDREN. (2) PERIODICALLY, MEASURE THE INTERVAL BETWEEN THE CLAMP CLAMP TO ENSURE THAT THIS IS WITHIN THE MANUFACTURER SPECIFICATIONS. THE USE OF EQUIPMENT WITH INAPPROPRIATE CLOSURE OPENING CAN ALLOW THE PENIS PONY TO BE PULLED UNDERVERTED BY THE CLAMP WITH THE PREPARATION CAUSING INJURY. FOR FURTHER INFORMATION, PLEASE CONTACT SHERRY PURVIS-WYNN, CDRH, BY EMAIL AT PHANN@CDRH.FDA.GOV OR MAIL AT OFFICE OF SURVEILLANCE AND BIOMETRICS (HFZ-510), 1350 PICCARD DRIVE, ROCKVILLE MD 20850 ; BY PHONE 1 (301) 594-0650; OR FAX (301) 594-2968.