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

Catalog Number 544965

Device Problem Material Twisted/Bent (2981)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported that "the jaws of the applier was found bent after a surgery.The procedure was completed without problem.Nothing fell/remained in the patient and no patient injury occurred)".The patient status is reported as "fine".

Manufacturer Narrative

Qn# (b)(4).

Manufacturer Narrative

(b)(4).The reported complaint of applier jaws - misaligned was confirmed upon the investigation of the returned sample.Evaluation of the returned device shows that the jaws are slightly loose and misaligned to each other in the closed position.There is no visible damage to the jaw pivot pin area on the outer tube assembly.The instrument was disassembled for further evaluation, and it was that the inner drive rod bosses were both damaged where they engage the jaws.The damaged drive rod bosses were suspected to have caused the jaws to become slightly loose and misaligned in the closed position.It could not be conclusively determined what caused what caused the drive rod bosses to become damaged but mishandling of the device at the end user's facility is suspected.The device history record for the returned instrument was reviewed and was found without any irregularities.The dhr of the returned sample was reviewed and no irregularities were identified.All 50 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.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "the jaws of the applier was found bent after a surgery.(the procedure was completed without problem.Nothing fell/remained in the patient and no patient injury occurred)".The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint of applier jaws - misaligned was confirmed upon the investigation of the returned sample.Evaluation of the returned device shows that the jaws are slightly loose and misaligned to each other in the closed position.There is no visible damage to the jaw pivot pin area on the outer tube assembly.The instrument was disassembled for further evaluation, and it was that the inner drive rod bosses were both damaged where they engage the jaws.The damaged drive rod bosses were suspected to have caused the jaws to become slightly loose and misaligned in the closed position.It could not be conclusively determined what caused what caused the drive rod bosses to become damaged but mishandling of the device at the end user's facility is suspected.The device history record for the returned instrument was reviewed and was found without any irregularities.The dhr of the returned sample was reviewed and no irregularities were identified.All 50 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.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported that "the jaws of the applier was found bent after a surgery.(the procedure was completed without problem.Nothing fell, remained in the patient and no patient injury occurred)".The patient status is reported as "fine".

• Brand Name: HOL ML 5MM ENDO APPLIER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17817986
• MDR Text Key: 324264533
• Report Number: 3003898360-2023-01371
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 34026704623625
• UDI-Public: 34026704623625
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 06A2244689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1