MAUDE Adverse Event Report: CONMED CORPORATION 6IN FLAT BLADE ELECTRODE,EXTENDED INSULATION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	138110
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
Investigation of the customer's complaint of an insufficient heat seal leading to a breach in sterility has confirmed the reported issue.Conmed received three 138110 unopened in original packaging, the reported catalog and lot numbers were verified.A visual inspection found the packaging sealed slanted, leaving gaps in the seal of two devices.A functional inspection was then performed and the devices were dye leak tested per policy.The dye leak test indicated that the packaging of one device had an insufficient heat seal.The dye leaked into the gap in the seal.The two other devices did not have an abnormalities or defects.The manufacturing documents from the device history record have been reviewed and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found no other similar events reported for this lot number.A two-year review of complaint history revealed there has been a total of 56 complaints, regarding (b)(4) 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).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Also per the ifu the user is advised that sterility is guaranteed unless package has been opened, broken, or damaged.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, 6in flat blade electrode,extended insulation, catalog # 138110, lot 201909091, for a possible breach of sterility due to an insufficient heatseal.There was no contact with any patient as this was found during incoming inspection in (b)(6).The completion of the device evaluation confirmed an insufficient heatseal.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: 6IN FLAT BLADE ELECTRODE,EXTENDED INSULATION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 11881890
• Report Number: 1320894-2021-00230
• Device Sequence Number: 3709893
• Product Code: GEI
• UDI-Device Identifier: 30653405003452
• UDI-Public: (01)30653405003452(17)240907(10)201909091
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: No Information
• Device Expiration Date: 09/07/2024
• Device Model Number: 138110
• Device Catalogue Number: 138110
• Device Lot Number: 201909091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1