MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; APPLIER, SURGICAL, CLIP

Catalog Number 544230

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2018

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

It was reported that the hem-o-lok applier was difficult to slid the jaw to load the clip from the cartridge and the clips are not ligating properly during surgery.The patient's condition is unknown at this time.

Manufacturer Narrative

(b)(4).Dhr review could not be conducted since the lot number provided is not a valid number for (b)(4) facility.A verification of failure mode reported in the current manufacturing process was conducted as follows: (b)(4) were taken from the current production p/n 544230 hemolok ml clips lot# 73c1800159, the samples were functionally inspected, and during the inspection issue reported "improper clip closure" was not observed in the current manufacturing process.Revision of (b)(4) was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the other remarks: alleged defect samples become available at a later date, this complaint will be updated accordingly.

Event Description

It was reported that the hem-o-lok applier was difficult to slid the jaw to load the clip from the cartridge and the clips are not ligating properly during surgery.The patient's condition is unknown at this time.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7296033
• MDR Text Key: 101125518
• Report Number: 3003898360-2018-00107
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544230
• Device Lot Number: 06K1525299
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1