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

Model Number IPN915189

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 03/17/2023

Event Type  malfunction  

Event Description

It was reported that "the applier did not function properly during use, so it was replaced with a new one to complete the surgery.Nothing fell/remained in the patient.The applier was sent to our technical specialist, who confirmed misalignment of the jaws.Also, he confirmed that the pivot pin was loose and that the rotation knob did not turn smoothly".No patient harm or injury.

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "the applier did not function properly during use, so it was replaced with a new one to complete the surgery.Nothing fell/remained in the patient.The applier was sent to our technical specialist, who confirmed misalignment of the jaws.Also, he confirmed that the pivot pin was loose and that the rotation knob did not turn smoothly".No patient harm or injury.

Manufacturer Narrative

(b)(4).The reported complaint of loose parts - applier jaw pin was confirmed based upon the sample received.Visual evaluation of the returned instrument revealed that the jaws are slightly loose and misaligned to each other in the closed position and the jaw pivot pin is slightly sticking out on one side is slightly sticking out on one side of the outer tube assembly and it was returned with a non-teleflex luer flush port cap.Functional evaluation identified that instrument was able to pick-up, retain, close and release multiple clips but will not close a clip over the silastic test tubing which is required of its function.It was also noted that the knob rotation mechanism is dry and sluggish feeling and difficult to rotate and in need of proper lubrication.After the initial evaluation of this instrument, we applied a few drops of non-silicone-based instrument lube into the luer flush port, and it was noted that the knob rotational mechanism was restored to normal smooth clocking feel and was no longer sluggish and difficult to rotate.This instrument was also disassembled to evaluate its internal components and it was found that one of the inner drive rod bosses that engage the jaws was damaged.The damaged drive rod boss was suspected to have caused the jaws to become slightly loose and misaligned in the closed position.It could not be conclusively determined what caused the drive rod boss to become damaged and for the jaw pivot pin to be slightly sticking out on one side of the outer tube assembly and for the knob rotation mechanism to be dry and sluggish feeling and difficult to turn.A dhr review was performed, and no evidence was found to suggest a manufacturing related cause.The root cause for this issue are likely the mishandling and lack of proper lubrication of the device at the end user's facility.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16795163
• MDR Text Key: 313819619
• Report Number: 3011137372-2023-00111
• 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: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPN915189
• Device Catalogue Number: 544965
• Device Lot Number: 06G2003394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2023
• 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