MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOCK LIGATING CLIP APPLIERS; APPLIER, SURGICAL, CLIP

Catalog Number 544965

Device Problems Difficult to Open or Remove Packaging Material (2922); Mechanics Altered (2984)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 09/21/2022

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 the surgeon had a bleeder because the clip was no closed properly they have had issued with appliers not repaired or replaced.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The dhr for the returned instrument was reviewed and found completely without any irregularities.According to the manufacturer, this instrument was produced at the manufacturing facility as part of a (b)(4) pc.Lot in july of 2021.It was found that this order was made from the correct materials and components and all approved processes were followed.It can then be stated that the alleged non-conformance inciting this complaint was not due to an error in the manufacturing process.Evaluation of this instrument as received shows that the outer tube assembly is bent/damaged and the jaw to handle mechanism is binding and sluggish due to the damaged/bent outer tube assembly.As stated on customer supplied paperwork this instrument has been mishandled at the end user's facility and this is the suspected root cause for the outer tube to be bent/damaged and for the handle to jaw mechanism to be binding and sluggish.All (b)(4) instruments from this lot were 100% visually inspected and function tested prior to shipment to the customer as this is a standardized procedure at this facility for this product line.Due to these findings, no further actions will be taken in_ response to this complaint and this record will be deemed closed.

Event Description

It was reported that the surgeon had a bleeder because the clip was no closed properly they have had issued with appliers not repaired or replaced.The patient's condition was reported as fine.

• Brand Name: HEMOLOCK LIGATING CLIP APPLIERS
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15521415
• MDR Text Key: 300990191
• Report Number: 3003898360-2022-00533
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 02402670469681
• UDI-Public: 2402670469681
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965
• Device Lot Number: 06E2002051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention