MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL APPLIER XL 11" RA; APPLIER, SURGICAL, CLIP

Model Number IPN915179

Device Problem Mechanical Jam (2983)

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

Event Date 01/30/2023

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

Reported issue: the clip did not easily leave the applier after ligation during a surgery.Therefore, the user replaced the applier with a new unit to complete the operation.No clip fell/remained in the patient.

Event Description

Reported issue: the clip did not easily leave the applier after ligation during a surgery.Therefore, the user replaced the applier with a new unit to complete the operation.No clip fell/remained in the patient.

Manufacturer Narrative

Qn# (b)(4).The dhr for the returned instrument was reviewed and found complete without any irregularities.This instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4) pc.Lot in march of 2020.It was found that this order was made from the correct materials and components and all approved processes were followed.Evaluation of the returned instrument as received shows that the open tip set gap is undersized.We were unable to load a clip properly to perform a function test due to the open tip set gap being undersized.Further evaluation shows that there are some markings behind the eyelets on both of the jaws.We are unable to determine what caused the tip set on this device to be undersized making it difficult to properly load a clip but tampering of the tip set or misuse of this device at the end user's facility is suspected.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.

Manufacturer Narrative

Qn#(b)(4).The dhr for the alleged defective instrument was reviewed and found complete without any irregularities.The alleged instrument was produced at the tecomet, inc.Kenosha, wi facility as part of a (b)(4) pc.Lot in march of 2020.It was found that this order was made from the correct materials and components and all approved processes were followed.This instrument has not been returned for review or evaluation therefore we are unable to determine what may have caused the alleged defect or validate the alleged complaint.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

Reported issue: the clip did not easily leave the applier after ligation during a surgery.Therefore, the user replaced the applier with a new unit to complete the operation.No clip fell/remained in the patient.

• Brand Name: HOL APPLIER XL 11" RA
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16433182
• MDR Text Key: 310160670
• Report Number: 3011137372-2023-00025
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696806
• UDI-Public: 24026704696806
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915179
• Device Catalogue Number: 544192
• Device Lot Number: 06F1871026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED