MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LIGASURE MARYLAND 37CM FT10 COMPATIBLE

Catalog Number LF1937CRH

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, during a laparoscopic case, a surgeon noticed a tiny sliver of white in the patient, which she presumed was from the ligasure.She attempted to grasp it, but it was not found again." due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, attempted medical intervention and in an abundance of caution, this medwatch is being filed.Sample has been returned for evaluation.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, during a laparoscopic case, a surgeon noticed a tiny sliver of white in the patient, which she presumed was from the ligasure.She attempted to grasp it, but it was not found again.

Manufacturer Narrative

Supplemental documentation changed/additional information added.D9 device available for evaluation -n/a.G6 type of report - follow-up.H2 if follow-up what type? additional information, device evaluation.H3 device evaluated by manufacturer - yes.H6 type of investigation- 10.H5 investigation conclusion - this reported issue was not confirmed.H10 investigation report reads as follows: investigation results: 07/15/2021 (b)(6) "confirmed that the received device was reprocessed by medline renewal.It had one medline renewal reprocessing mark and was associated with lot 439906, as confirmed by the returned product label.The customer reported that a white sliver (presumably from the device jaws) was noted in the patient and was unable to be retrieved.I inspected the device jaws as received.Ligasure devices have a light gray plastic layer on each side of the jaws that houses the metal/activation surface.Upon initial inspection, i observed debris in the jaws indicating typical use, but there was no evidence of excessive debris indicating that the device was over-used.I did not observe any damage or missing pieces of the jaws during initial inspection.Due to the presence of the debris, it made it difficult to fully inspect the light gray plastic layer(s).I cleaned the device jaws so that no debris remained.Upon the second inspection, i was still unable to see any broken components and did not observe any damage to the device.This reported issue was not confirmed.".

Event Description

It was reported, during a laparoscopic case, a surgeon noticed a tiny sliver of white in the patient, which she presumed was from the ligasure.She attempted to grasp it, but it was not found again.

• Type of Device: LIGASURE MARYLAND 37CM FT10 COMPATIBLE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12143973
• MDR Text Key: 263130336
• Report Number: 3032391-2021-00013
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LF1937CRH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention