MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) ENDOSTAT; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-0612

Device Problems Break (1069); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

It was reported that at the completion of a diagnostic laparoscopy procedure, a piece of the fiber broke off into the patient and was never located to be removed.There was no patient issues" reported.

Manufacturer Narrative

Product evaluation: failure analysis for fiber (b)(4): the fiber is broken and detached 9 feet and 7.5 inches from connector; the second piece consisting of distal tip was not returned; the outer cladding appears stretched and stressed at break location; the fiber was tested with hene laser fixture, aim beam is visible at the break location.Probable root cause: based on the device analysis, the probable root cause of the failure is: excessive bending.

Event Description

Fiber used for 432 joules.

• Brand Name: ENDOSTAT
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• Manufacturer Contact: jennifer mascioli-tudor ; 3070 orchard drive; san jose, CA 95134 ; 4084563300
• MDR Report Key: 6823462
• MDR Text Key: 83972201
• Report Number: 2937094-2017-00754
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953000077
• UDI-Public: (01)00878953000077(11)170330(17)200330(10)0612714
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Model Number: 0010-0612
• Device Catalogue Number: 0010-0612
• Device Lot Number: 714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1