MAUDE Adverse Event Report: CONMED CORPORATION 5MM L-HOOK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	60-5274-132
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One 60-5274-132 was received in opened original packaging, the reported catalog and lot numbers were verified.Inspection of the device found that the sheath was loose.Due to the loose sheath, this device is considered defective.A review of the dhr found no anomalies that would contribute to this issue.A two-year review of complaint history revealed there has been a total of 6 complaints, regarding 6 devices for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; examine the device prior to use for damage.Do not use if damage is found.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
This distributor reported on behalf of their customer that the 60-5274-132 device shrink sleeve was not fixed into place.This was discovered during surgery and the device was not used; however, a similar failure mode has been reported within the past two years.Due to the explanation of the failure mode in that reporting, this event has the potential for injury due to this malfunction.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 5MM L-HOOK
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7948637
• Report Number: 1320894-2018-00214
• Device Sequence Number: 2337992
• Product Code: GEI
• UDI-Device Identifier: 00653405010732
• UDI-Public: (01)00653405010732(17)220802(10)201708031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 201708031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/09/2018
• Patient Sequence Number: 1