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

Catalog Number 544965T

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 01/20/2019

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 when the physician ligated the vessel the jaws on the applier broke and 2 small pieces approximately 1mm in size feel into the patient.The pieces were not removed.

Event Description

It was reported that when the physician ligated the vessel the jaws on the applier broke and 2 small pieces approximately 1mm in size feel into the patient.The pieces were not removed.

Manufacturer Narrative

(b)(4).Upon review of the device history records for the affected lot number, we can confirm that both the correct material and correct components had been used and that the instrument meets the product specifications.All process steps were found to have been properly documented.Prior to shipment, our instruments undergo a 100% functional inspection.If there had been any improperly inserted rivet, this would have been detected.As the draw rod ball of the insert is overstretched and strongly deformed , we suspect that it was damaged as a result of overstressing by applying massive pressure via the handle and/or an improper use.At (b)(6), no further measures will be initiated; this complaint is being rejected by us.The instrument in question will be scrapped by us unless any other instructions are received from you within 12 weeks.No further measures will be initiated by (b)(6); this complaint is being rejected by us.

• Brand Name: HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8331956
• MDR Text Key: 135943966
• Report Number: 3011137372-2019-00044
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 544965T
• Device Lot Number: 1100533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1