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

Model Number	LF1644
Medical Device Problem Codes	Detachment Of Device Component (1104); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 wire-like piece of the black sleeve became loose and fell into the patient's cavity.The piece was retrieved with laparoscopic graspers and no patient injury resulted.
Additional Manufacturer Narrative
Correction: (first, last name, facility), additional information: phone number, email evaluation summary: one used lf1644 device was received, and evaluation confirmed the reported condition.Visual inspection found the device was returned with damaged insulation.The investigation found the insulation on the rod shaft of the device was damaged and disengaged from the device.The insulation was scraped off of the rod shaft.The damage to the rod shaft insulation likely occurred during the insertion or 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 for use states, use the appropriately sized trocar to allow for easy insertion and extraction of the instrument.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: 6815525
• Report Number: 1717344-2017-05767
• Device Sequence Number: 1735485
• Product Code: GEI
• UDI-Device Identifier: 20884521210865
• UDI-Public: 20884521210865
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142929
• 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): 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2022
• Device Model Number: LF1644
• Device Catalogue Number: LF1644
• Device Lot Number: 71250112X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1