Alerta De Seguridad para HARMONIC ACE+ Shears with Adaptive Tissue Technology (23cm and 36cm)

Safety alert

2018-05-07

2018-05-07

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20180507a.html

Medical device safety alert: harmonic ace+ shears with adaptive tissue technology (23cm and 36cm) medical device manufacturer, ethicon endo-surgery, has issued a medical device safety alert concerning its harmonic ace+ shears with adaptive tissue technology (23cm and 36cm). the affected devices are identified as the following: product code [lot]: har23 [p9125c, p93t5j, p93t5k, p93v06, p93w0a, p93w4y, p93w8a, p93y4a, p93zax, p93z96, p9400f, p9409v, p94a93, p94a94, p94c8r, p94e6u, p94g1w, p94h32, p94h9v, p94j28]; har36 [n92923, n9392k, p9129w, p91394, p9139n, p9144r, p9148k, p9149j, p9168k, p9173r, p9174k, p91795, p91c51, p91c83, p91f2x, p91k69, p91l0h, p91l1y, p91l6e, p91l6j, p9396a, p9396c, p9399t, p93a1l, p93l47, p93l76, p93m5y, p93m6p, p93m6t, p93n00, p93n01, p93n3x, p93n3y, p93n5a, p93n7h, p93p09, p93p26, p93p2e, p93p7g, p93p7h, p93r0z, p93r10, p93r4f,p93r4g, p93r56, p93r57, p93r6u, p93r6v, p93t0x, p93t20, p93t26, p93t9l, p93u0p, p93u17, p93u5n, p93u90, p93u91, p93v02, p93v03, p93v0v, p93v57, p93v5t, p93w9r, p93w9x, p93x2g, p93x2w, p93x2x, p93x85, p93x98, p93y47, p93y48, p93y8x, p93z4t, p93z5x, p93z95, p94015, p9414t, p94a5k, p94a6a, p94c10, p94c11, p94c47, p94c5r, p94c8t, p94d0m, p94d0p, p94d3j, p94d3k, p94d5g, p94d9k. p94e1z, p94e20, p94e3z, p94e8w, p94f1m, p94f3a, p94f5t, p94f6c, p94f7l, p94g1h, p94g1j, p94h0k, p94h31, p94h4v, p94h8j]. according to the manufacturer, through post-market surveillance efforts and per conducted investigation, it confirmed that some devices contained in these lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device. the medical assessment concluded that this situation may cause inadvertent mechanical or thermal damage to unintended tissue if the continuous or inadvertent activation occurs when used in operative cases. to date, there are no reports of adverse events associated with the issue that led to this recall. the manufacturer has identified the root cause have implemented immediate corrective actions to address the issue. the affected users are required to: examine their inventory immediately to determine if they have product lots subject to the recall on hand and quarantine such products; remove the product lots subject to the recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in their facility who needs to be informed; and health care practitioners who have treated patients using the affected products should follow those patients post-operatively in the usual manner with no additional action required. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 may 2018.