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

Model Number S-LLF550

Device Problem Kinked (1339)

Patient Problem Burn, Thermal (2530)

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "a kink was noted in the holmium laser fiber.When the technician activated the laser and went to fix the kink, he received a burn to his hand." no patient was involved.This event occurred prior to the procedure starting.A new fiber was used for the bronchoscopy procedure.Patient outcome: no report of injury to the patient.

Manufacturer Narrative

(b)(4).No code available was selected as the follow-up information from risk management at the hospital indicated the technician has an "ouch to the palm of his hand".Not a burn.

Event Description

It was further reported that the technician had a "burn to the palm of the hand"."it was really an ouch" but he was sent to occupational health for evaluation.No treatment was given and he returned immediately to work.Another sureflex fiber was used in the case.The laser was verified as (b)(4).Patient status: "fine" there was no further information reported.

• Brand Name: SUREFLEX FIBERS
• 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: 5855121
• MDR Text Key: 51443758
• Report Number: 2937094-2016-00799
• Device Sequence Number: 1
• Product Code: GEX
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: S-LLF550
• Device Lot Number: 329A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2013
• 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