MAUDE Adverse Event Report: CONMED UTICA ELEC,BLDE,LNG,EXT,INSULATD,40; 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 returned unopened in original packaging.The lot number of the device: 201910141 was verified.A visual inspection found the packaging of two devices had a gap in the heat seal.The clear side of the packaging was separated from the paper side leaving a gap with one packaging having a small open hole.The third device had an inconsistent seal, leaving small folds along seal.A functional inspection was then performed, on the third device which did not have an obvious breach.The device was dye leak tested per policy.The dye leak indicated the packaging of the third device did not have an insufficient heat seal.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 found found this is the only event with a quantity of 3 units for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 73 complaints, regarding 354 devices, for this device family and failure mode.During this same time frame 2,009,820 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.The ifu also advises the user 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, catalog # 138110, lot 201910141, 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; therefore, this complaint meets the criteria for a reportable event.Due to the breach in sterility, this report is being raised as a malfunction with potential for injury upon reoccurrence.

• Brand Name: ELEC,BLDE,LNG,EXT,INSULATD,40
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• MDR Report Key: 12367933
• Report Number: 1320894-2021-00341
• Device Sequence Number: 3974185
• Product Code: GEI
• UDI-Device Identifier: 30653405003452
• UDI-Public: (01)30653405003452(17)241012(10)201910141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K943542
• 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): 08/24/2021

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: 10/12/2024
• Device Model Number: 138110
• Device Catalogue Number: 138110
• Device Lot Number: 201910141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1