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 Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, "the md ligated a clip with the applier during a surgery, but it was not ligated firmly because the applier jaw pin was loosened.That caused cutting the vessel and bleeding in the patient's body.Therefore, the md performed hemostasis and the patient recovered.No clip fell/remained in the patient.".

Event Description

It was reported that, "the md ligated a clip with the applier during a surgery, but it was not ligated firmly because the applier jaw pin was loosened.That caused cutting the vessel and bleeding in the patient's body.Therefore, the md performed hemostasis and the patient recovered.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 50-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.Evaluation of the returned instrument as received shows that it is complete and not missing any of its components.Visual evaluation shows that the jaws are loose and misaligned and bent to the right and the jaw pivot pin is pulled thru one side of the bent/damaged outer tube assembly.Further evaluation shows that knob rotation and handle to jaw mechanisms are both dry and sluggish feeling and in need of lubrication.We are able to validate this complaint.After the initial evaluation this instrument was dis-assembled in order to evaluate its internal components by removing the luer flush port and it was found that the inner drive rod (n00185) is bent, and its 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 knob and handle to jaw mechanism to be dry and sluggish feeling and for the drive rod to become bent and for its bosses to become damaged and for the jaws to be bent to the right and for the jaw pivot pin to be pulled thru one side of the bent/damaged outer tube assembly but mishandling and lack of proper lubrication 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 actions will be taken in response to this complaint and this record will be deemed closed.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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16709358
• MDR Text Key: 312980134
• Report Number: 3011137372-2023-00081
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• 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: 06E2002042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1