MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF3225
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a hemorrhoidectomy, the device had an incomplete seal, they adjusted it and re-tried it three times, then they abandoned the device and used a cautery device.There was no patient injury.
Event or Problem Description
According to the reporter, during a hemorrhoidectomy, the device had an incomplete seal, reassembled the device and reconnected it to the generator for three times and nothing happened, there was no cut nor cauterizing of tissues, then they abandoned the device and used a cautery device(regular monopolar) with the same generator.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the plastic snap tabs were broken.The broken pieces were not returned.The knife was also bent.The reported condition was confirmed.Inspection found the plastic snap tabs that allow the disposable part to snap on to the non-disposable clamp were broken by excessive repeated force by the user.The broken pieces were not returned.The presence of the blue wrap around the wire probably indicates that the device was not used on the patient.The observed damage could have been caused prior to assembly by putting excessive force during assembly onto a set of forceps (or, clamp).The knife was bent and would not extend or retract.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 9552666
• Report Number: 3006451981-2020-00003
• Device Sequence Number: 19322778
• Product Code: GEI
• UDI-Device Identifier: 10884521197183
• UDI-Public: 10884521197183
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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: LF3225
• Device Catalogue Number: LF3225
• Device Lot Number: S9EJ00PX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1