MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK HOL ML 5MM ENDO APPLIER

Catalog Number 544965

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

Complaint alleges that during a laparoscopic gastrectomy procedure the jaws were misaligned and the clip couldn't be locked.The clip did fall into the pt, but it was removed and discarded and no medical intervention was performed.No pt injury reported.Pt current condition is fine.

Manufacturer Narrative

(b)(4).The device sample was not rec'd by the mfr at the time of this report.

• Brand Name: WECK HOL ML 5MM ENDO APPLIER
• Type of Device: ENDO APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck dr; research triangle park NC 27709
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4752190
• MDR Text Key: 15140632
• Report Number: 1044475-2015-00165
• Device Sequence Number: 1
• Product Code: GEF
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 544965
• Device Lot Number: 06B1498868
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1