MAUDE Adverse Event Report: TELEFLEX MEDICAL HEM-O-LOK XL ENDO 10, APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544990

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a clip was not detached from the applier after ligating ureter during a laparoscopic nephrectomy.The user got it detached by grasping it by forceps after nephrectomy.When the user tested to ligate outside the cavity later, the same issue occurred several times.The procedure was delayed by 5 minutes.An additional procedure was performed using a bipolar to cut the ureter at the ligation site.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.This instrument was produced at the tecomet , inc kenosha facility as part of a (b)(4) pc.Lot in (b)(6) of 2015.Evaluation of the returned device shows that the luer flush port cap is missing.Further evaluation shows that the jaws are not damaged in any way.Functional testing shows that this instrument is able to pick-up , retain, close and release multiple clips both with and without the use of silastic test tubing.We are unable to validate this complaint since we are unable to replicate the alleged issue.We are unable to determine what caused the alleged issue at the end user's facility.All 50 instruments from this lot were 100% visually inspected and function tested prior to release to customer as this is a standardized procedure at this facility for this product line.

Event Description

It was reported that a clip was not detached from the applier after ligating ureter during a laparoscopic nephrectomy.The user got it detached by grasping it by forceps after nephrectomy.When the user tested to ligate outside the cavity later, the same issue occurred several times.Additional information: the procedure was delayed by 5 minutes.An additional procedure was performed using a bipolar to cut the ureter at the ligation site.

• Brand Name: HEM-O-LOK XL ENDO 10, APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10179043
• MDR Text Key: 195929308
• Report Number: 3011137372-2020-00136
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544990
• Device Lot Number: 06A1496916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/22/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention