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

Model Number IPN915189

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/29/2023

Event Type  malfunction  

Event Description

It was reported that "the user was unable to load a clip to the applier during use.Therefore, another applier was used to complete the procedure.No clip fell/remained in the patient.On checking the applier, the jaws were found bent." no patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).The complaint sample was returned.Tecomet, the manufacturing site reported " the dhr for the returned instrument was reviewed and found complete without any irregularities.These instruments were produced as part of a (b)(4) pc.Lot in march of 2022.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 shows that the tips are slightly loose and misaligned in the closed position.Function testing of this device shows that it is able to pick-up, retain, close and release multiple clips both with and without the use of silastic test tubing as required of it function.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components and it was found that the inner drive rod bosses are both damaged where they engage the jaws.We suspect that the damaged drive rod bosses caused the jaws to become slightly loose and misaligned in the closed position.We are unable to determine what caused the drive rod bosses to become damaged but mishandling of this device at the end user's facility is suspected.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 action will be taken in response to this complaint and this record will be deemed closed." other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the user was unable to load a clip to the applier during use.Therefore, another applier was used to complete the procedure.No clip fell/remained in the patient.On checking the applier, the jaws were found bent." no patient harm or injury.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; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17318144
• MDR Text Key: 319108835
• Report Number: 3011137372-2023-00183
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 24026704696813
• UDI-Public: 24026704696813
• 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
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915189
• Device Catalogue Number: 544965
• Device Lot Number: 06A2244656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2023
• 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: Initial
• Patient Sequence Number: 1