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

Catalog Number 544965T

Device Problems Unintended Ejection (1234); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician found that the clips cannot be loaded by the jaw of the applier, the clip fell into the patient's body and it was removed by using another applier.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The jaw was measured and some clips were taken and pressed on a test tube.The measurement test showed that the instrument is within specification.The clips could be taken and pressed on the test tube.There were no deviations.It was determined that the tractive wire ball is bent.This has no effect on the complaint which is described by the customer.This damage is caused by overload.When reviewing the device history record of the applicable lot, it could be confirmed that the right material and all specified and required components have been used.All defined and specified working steps are recorded on the working sheet.The error could not be reproduced.The instrument is within specification.Root cause unknown.No corrective action will be initiated on the instrument slight signs of usage are visible.Product can be repaired at customer's request.

Event Description

The physician found that the clips cannot be loaded by the jaw of the applier, the clip fell into the patient's body and it was removed by using another applier.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: 6586315
• MDR Text Key: 75822232
• Report Number: 3011137372-2017-00191
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 544965T
• Device Lot Number: G5-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2017
• 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