MAUDE Adverse Event Report: 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
The reported event of ¿insufficient heatseal¿ is confirmed.Two 138110 returned unopened in original packaging.The lot number of the devices, 202004271 was verified.A visual inspection found an open hole in the packaging of one device caused by the electrode encroaching into the seal.The second device was also encroaching into the seal of the packaging.The second device without an obvious breach was dye leak tested, which indicated an insufficient heat seal, the dye leaked.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 2 year lot history review was conducted and found this is the only event with a quantity of 2 units for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 77 complaints, regarding 378 devices, for this device family and failure mode.During this same time frame 1,972,470 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: 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, 138110, 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: ELEC,BLDE,LNG,EXT,INSULATD,40
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• MDR Report Key: 12751420
• Report Number: 1320894-2021-00400
• Device Sequence Number: 4558020
• Product Code: GEI
• UDI-Device Identifier: 30653405003452
• UDI-Public: (01)30653405003452(17)250426(10)202004271
• 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): 11/04/2021

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: 04/26/2025
• Device Model Number: 138110
• Device Catalogue Number: 138110
• Device Lot Number: 202004271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1