MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF1744
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
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 the laparoscopic gastric sleeve procedure, when it was connected to generator, at the time of resection- at about the 10th sealing; it was stated that the inner side of the jaws peeled off after the device was released from the tissue.It was still connected by a part of the tip, it was not completely removed.It seemed that there was no problem with the seal itself.After that, a new product was used without problem, so the operation was continued.Nothing fell into the patient's cavity.No patient harm.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the bottom jaw overmold was damaged and the seal plate was lifted up from the device jaw.There was no missing piece on the damaged overmold or seal plate.The reported condition was confirmed.The investigation found the bottom jaw overmold was damaged and the bottom jaw seal plate was lifted up from the jaw.The damage to the jaw's overmold and seal plate likely occurred during the extraction of the device jaw from a trocar instrument.The investigation identified the root cause of the reported event to be user error.The instructions fpr use (ifu) states, carefully insert and withdraw the instrument through the cannula to avoid damage to the device and or injury to the patient.Close jaws using device handle before insertion/extraction in the trocar.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 MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8191946
• Report Number: 1717344-2018-01667
• Device Sequence Number: 2112486
• Product Code: GEI
• UDI-Device Identifier: 10884521181564
• UDI-Public: 10884521181564
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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 Expiration Date: 12/20/2022
• Device Model Number: LF1744
• Device Catalogue Number: LF1744
• Device Lot Number: 73550223V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1