MAUDE Adverse Event Report: TELEFLEX MEDICAL HOR ENDO CLIP APPLIER MED-LG; APPLIER, SURGICAL, CLIP

Catalog Number 338110

Device Problems Unintended Movement (3026); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(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 the pivot pin of the applier handle was so loose that it often fell.According to the user, the pin had fallen since the device's purchase in (b)(6) 2017 so often that he/she kept avoiding using it as much as possible.However, at the fifth use in (b)(6) 2018, the pin fell, not in the patient but somewhere outside surgical field, and was missing.No patient injury occurred, however, the user stopped using the device.Then, having compared it to a replacement device, the user found that the pivot pin of the former was much looser than the latter and doubted it was defective.

Event Description

It was reported that the pivot pin of the applier handle was so loose that it often fell.According to the user, the pin had fallen since the device's purchase in june 2017 so often that he/she kept avoiding using it as much as possible.However, at the fifth use in december 2018, the pin fell, not in the patient but somewhere outside surgical field, and was missing.No patient injury occurred, however, the user stopped using the device.Then, having compared it to a replacement device, the user found that the pivot pin of the former was much looser than the latter and doubted it was defective.

Manufacturer Narrative

Qn#(b)(4).The dhr for the alleged instrument was reviewed and found completely without any irregularities.This instrument is part of a 50 pc.Lot originally produced at the aesculap inc.In germany in february of 2015 and purchased by the tecomet, inc.Kenosha facility and manufactured to teleflex medical print specifications as part of 25 pc.Order which was produced in february of 2015.The returned instrument was evaluated , and it was found that it is missing the handle pivot screw thus we are able to validate the complaint.Further evaluation showed that the luer port cap was missing as well as this instruments handle to jaw mechanism feels sluggish and binds in multiple positions while turning the knob assembly.We are unable to determine what caused the handle pivot screw to become loose and fall out during a procedure but mishandling of the device is suspected since the handle to jaw mechanism binds in multiple positions while turning the knob assembly.All of the instruments from this lot were 100% visually inspected and function tested prior to shipment to customer as this is a standardized procedure for this product line at this facility.

• Brand Name: HOR ENDO CLIP APPLIER MED-LG
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8433154
• MDR Text Key: 139222019
• Report Number: 3011137372-2019-00068
• 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: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338110
• Device Lot Number: 06J1408023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1