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

Model Number	0010-0612
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
Fiber used for 432 joules.

• Brand Name: ENDOSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE); 3070 orchard drive; san jose CA 95134
• MDR Report Key: 6823462
• Report Number: 2937094-2017-00754
• Device Sequence Number: 1324143
• Product Code: GEX
• UDI-Device Identifier: 00878953000077
• UDI-Public: (01)00878953000077(11)170330(17)200330(10)0612714
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1