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

Model Number	LS1520
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
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 the nephrectomy, the jaws of the device would not open, and the device could not cut.The procedure was completed with another device.The product did not lock on tissue and was removed from the tissue without damaging it.Additional tissue resection was not required.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The jaws opened and closed properly when the handle was retracted and released.The knife blade advanced and retracted smoothly along the knife track.The knife cut of the device was tested on a silicone test strip with acceptable results.The knife blade was also inspected under microscope and no issue was found.The investigation found the device to function normally and within specifications.The instructions for use (ifu) states, keep the instrument jaws clean.Build up of eschar may reduce sealing and/or cutting effectiveness.Wipe jaw surfaces and edges with a wet gauze pad as needed.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: 8468965
• Report Number: 3006451981-2019-00054
• Device Sequence Number: 1104108
• Product Code: GEI
• UDI-Device Identifier: 40884524002188
• UDI-Public: 40884524002188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019

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: 05/30/2023
• Device Model Number: LS1520
• Device Catalogue Number: LS1520
• Device Lot Number: S8EB014X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Initial Date Received by Manufacturer: 03/09/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1