MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL ML 5 MILLIMETER ENDO APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problems Break (1069); Positioning Failure (1158); Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  malfunction  

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 after two hours from the start of surgery, the applier failed to ligate the splenic artery 2nd clipping.When the surgeon grasped the handle, the tip of the applier broke.The user felt that the screw that holds jaws became loose or misaligned.It was suspected that the part from the broken applier was left in the patient.The part was not found in x-ray and the procedure was completed.The broken part was not found in the collected organs or gauze.

Manufacturer Narrative

Qn#(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 50pc.Lot in august of 2017.The returned instrument and provided photos were evaluated and found that the jaws are loose and misaligned, and the pivot pin is pulled partially into the tube assembly.The tube assembly and the drive rod both are damaged/bent at the jaw end.As received this instrument is complete and not missing any components from the jaw end of the device but it was returned without the removable flush port cap which covers the flush port on the knob assembly.We are able to validate the alleged complaint since this device is unusable in its current state.All instruments from this product line are 100% visually inspected and function tested prior to shipping to customer as this is a standardized procedure at this facility.We are unable to determine what caused the tube assembly and drive rod to become bent/damaged and for the jaws to be loose and misaligned , but mishandling of this device at the end users facility is suspected.

Event Description

It was reported that after two hours from the start of surgery, the applier failed to ligate the splenic artery 2nd clipping.When the surgeon grasped the handle, the tip of the applier broke.The user felt that the screw that holds jaws became loose or misaligned.It was suspected that the part from the broken applier was left in the patient.The part was not found in x-ray and the procedure was completed.The broken part was not found in the collected organs or gauze.

• Brand Name: HOL ML 5 MILLIMETER ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8041298
• MDR Text Key: 126385136
• Report Number: 3011137372-2018-00298
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06C1748160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1