MAUDE Adverse Event Report: TELEFLEX MEDICAL HOL L ENDO APPLIER 10MM, 45CM

Catalog Number 544995L

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2015

Event Type  malfunction  

Event Description

Alleged event: it was reported that the clips do not pinch and there is a strange (zink) coating on instrument.Robotic surgery for prostatectomy was performed the clips never locked when tissue was found between the jaws.The patient's condition was reported as fine.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The surgery was a robotic prostatectomy.The device history review for the hol l 10mm endo applier, 45cm, was reviewed and found complete without any irregularities.Evaluation and function checking of the returned instrument showed that the jaws of the instrument are aligned properly and the instrument picks-up, retains, closes and releases multiple clips over test tubing as required of its function.We are unable to determine what caused the alleged issue.Parts were 100% visually inspected and tested by the manufacturer before release and no irregularities were found or reported at the time of inspection or assembly.No corrective action is required at this time however, the manufacturer will continue to monitor and trend related events.

• Brand Name: HOL L ENDO APPLIER 10MM, 45CM
• Type of Device: APPLIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park; research triangle park NC
• Manufacturer (Section G): TELEFLEX NADC; 11245 n distribution cove; olive branch MS 38654
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 4791394
• MDR Text Key: 19605458
• Report Number: 3010041511-2015-00001
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 544995L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1