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

Model Number	LF1537
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during a procedure, a jaw component detached from the device with initial use.The component did not fall within the patient cavity.No patient injury occurred.
Additional Manufacturer Narrative
Evaluation summary: one used lf1537 ligasure device was returned, and an examination of the sample confirmed an issue with a detached component.Visual inspection found the metal flange that pulls the inner tube to open the jaw had broken off.The issue also allowed the knife blade to be deployed while the jaws were open.The tube is made of stainless steel and should not break without excessive force or abuse.The damage to the metal flange 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 misuse.The instructions incuded with this product cautions users that this is a single use device.It has only been evaluated in testing to simulate single use conditions.Subjecting the product to reprocessing or multiple uses could potentially impact the structure and components of the device.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: 6836323
• Report Number: 1717344-2017-05836
• Device Sequence Number: 13810606
• 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,Followup
• Report Date (Section B): 10/27/2017

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: 50160222X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 08/09/2017
• Supplement Date Received by Manufacturer: 10/04/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1