MAUDE Adverse Event Report: CONMED CORPORATION 5MM,SPATULA W/STEALTH,32 CM /; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60-5274-032
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported unused device was returned for evaluation in its original unopened package.Label verification and visual inspection were performed.The device was observed to have a hole in the packaging tyvek adjacent to the distal end of the device.This defect resulted in a breach of sterility.Due to the location and appearance of the defect, it is likely that the device caused the hole in the packaging.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 5 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 this 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
The distributor in (b)(6) reported a "damage" on the sterile pouch of this (b)(4), 5mm,spatula w/stealth,32 cm.There was no patient involvement as this defect was discovered during incoming inspection.This report is raised on the basis of a device malfunction due to a sterility breach found during the device evaluation.

• Brand Name: 5MM,SPATULA W/STEALTH,32 CM /
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7486301
• Report Number: 1320894-2018-00096
• Device Sequence Number: 1216492
• Product Code: GEI
• UDI-Device Identifier: 30653405010702
• UDI-Public: (01)30653405010702(17)220625(10)201706261
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: Other
• Device Expiration Date: 06/25/2022
• Device Model Number: 60-5274-032
• Device Catalogue Number: 60-5274-032
• Device Lot Number: 201706261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/04/2018
• Patient Sequence Number: 1