MAUDE Adverse Event Report: CONMED CORPORATION ABC; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	160656
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When trying to open product in sterile field, the outer paper separated from the plastic packaging.This made opening difficult and brought into questioning sterility of the product once opened.Potential harm is in using an unsterile product.

• Brand Name: ABC
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 10927090
• Report Number: 10927090
• Device Sequence Number: 2671734
• Product Code: GEI
• UDI-Device Identifier: 30653405003896
• UDI-Public: (01)30653405003896
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020
• Report Date (Section F): 11/25/2020

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 Model Number: 160656
• Device Catalogue Number: 160656
• Device Lot Number: 201808154
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/25/2020