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

Model Number	LF1537
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one lf1537 ligasure device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.The returned product did not meet specification as received.The customer reported the device was difficult to close.The reported condition was confirmed.Investigation found that the jaws of the device could not close when the handle latch was retracted.The metal flange that pulls the inner tube to open the jaw was broken and had disengaged from the device jaw.The tube is made of stainless steel and should not break without exerting excessive force or abuse.The damage to the metal flange of the device is consistent with a device that has been subjected to reprocessing or multiple uses.The investigation identified the root cause of the reported event to be the device not being used as intended.The instructions for use caution that this product is designed as a single use device.It has only been evaluated in testing to simulate single use conditions.Subjecting the product to reprocessing or multiple uses coul d potentially impact the structure and components of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device was difficult to close.The handle could not be used to operate the jaws.There was no patient injury.Evaluation of the returned device found that a piece of the jaws had broken off and was not returned.The customer was notified and confirmed that no piece of the device fell within the patient.

• 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: 7291280
• Report Number: 1717344-2018-00260
• Device Sequence Number: 11357397
• Product Code: GEI
• UDI-Device Identifier: 10884524002293
• UDI-Public: 10884524002293
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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: 02/28/2020
• Device Model Number: LF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 50160220X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1