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

Catalog Number 544965T

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The clip was adhered with the applier and the clip could not be separated from the jaw of the applier.After pulling the device, there was bleeding from the vessel.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).Dhr of the lot shows, that the right material and components were used and that the instrument meets all specification.All working steps were documented.Complaint instrument (b)(4) with lot no.G5-03 was received in (b)(6) on the (b)(6) 2017 and forwarded to the supplier for further investigation on the (b)(6) 2017.No obvious defects were found.The functional test shows no mistake.The product has definitely not left the facility in this condition, because 100% final inspection (surface & function) is performed prior to shipping.The damage could be caused during the reprocessing and/or sterilization process.The tip got stuck in the cleaning tray/basket or that another heavy instrument was placed on the tip of our tap hemolok and that's why the tip was deformed.However, the instrument can be reworked.

Event Description

The clip was adhered with the applier and the clip could not be separated from the jaw of the applier.After pulling the device there was bleeding from the vessel.The patient's condition was reported as fine.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Type of Device: APPLIER,SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6196533
• MDR Text Key: 63067796
• Report Number: 3011137372-2016-00364
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965T
• Device Lot Number: G5-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1