MAUDE Adverse Event Report: CONMED CHIHUAHUA GOLDLINE, ROCKER, HOLSTER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	130307A
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event of insufficient heat seal is confirmed.One 130307a returned unopened in original packaging.The lot number of the device (b)(4) was verified.A visual inspection found a gap in the seal caused by one side of the packaging lifting.A functional test was performed which indicated an insufficient heat seal.The dye leaked into the gap caused by the seal lifting.A 2 year lot history review found 2 events with a quantity of 3 units for this lot number and failure mode.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 was found to have met all specifications prior to shipment.A two-year review of complaint history revealed there has been a total of 77 complaints, regarding 159 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: these devices should be inspected before each use.Visually examine the devices for obvious physical damage including cracked, broken or otherwise distorted plastic parts.Damage including cuts, punctures, nicks, abrasions, unusual lumps significant discoloration.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
During incoming inspection, the distributor rejected this device, 130307a, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: GOLDLINE, ROCKER, HOLSTER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CHIHUAHUA; alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• MDR Report Key: 12385557
• Report Number: 3007305485-2021-00330
• Device Sequence Number: 14675539
• Product Code: GEI
• UDI-Device Identifier: 30653405056144
• UDI-Public: (01)30653405056144(17)240428(10)201904304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K791137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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: 04/28/2024
• Device Model Number: 130307A
• Device Catalogue Number: 130307A
• Device Lot Number: 201904304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1