MAUDE Adverse Event Report: MEDLINE RENEWAL COVIDIEN; LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR

Catalog Number LF1837CRH

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unspecified general laparoscopic case, the jaws of the reprocessed covidien ligasure blunt tip, sealer/divider, nano-coated, compatible with ft10 generator 37cm, partially split apart resulting in small shavings and metal shards to enter the wound.No information was provided on how the shavings or shards were retrieved from the patient's wounds.There was no serious injury reported related to this event.Due to the reported incident and in an abundance of caution, this medwatch is being filed.The sample was returned for evaluation and upon inspection of the received device, it was observed that there was a small staple lodged inside the device jaws.This was determined to be the root cause of the reported metal shards/shavings.The device jaws were not split or otherwise damaged.The source of the staple could not be confirmed at this time.The device had been reprocessed one time.A review of the device history record was performed and this review indicated that all processes were conducted as required at the time the reported lot was processed.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the jaws of the reprocessed covidien ligasure blunt tip partially split apart resulting in small shavings and metal shards to enter the wound.

• Brand Name: COVIDIEN
• Type of Device: LIGASURE BLUNT TIP, SEALER/DIVIDER, NANO-COATED, COMPATIBLE WITH FT10 GENERATOR
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 9369152
• MDR Text Key: 190750240
• Report Number: 3032391-2019-00028
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: LF1837CRH
• Device Lot Number: 419762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention