MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTAT; POWERED LASER SURGICAL INSTRUMENT

Model Number	0010-6110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the glass distal tip is fractured and melted.The total length of the fiber is 11 feet 10 inches.Based on the analysis results, excessive handling/bending of the fiber during use may be a factor leading to fiber tip fracture.An evaluation conclusion code of unintended use error caused or contributed to event was assigned to this investigation.
Event or Problem Description
It was reported that the fiber diminished power after 17 joules of use.The tip of the fiber appeared intact.There was no fiber breakage and no piece of the fiber tip detached inside the patients body.The fiber was replaced and the procedure completed with 9 joules of use.There was no patient harm as a result of the event.The fiber was returned and analysis found the fiber cap tip was found to be fractured.

• Brand Name: ACCUSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10436983
• Report Number: 2937094-2020-00753
• Device Sequence Number: 2949445
• Product Code: GEX
• UDI-Device Identifier: 00878953000121
• UDI-Public: 00878953000121
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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: 03/14/2022
• Device Model Number: 0010-6110
• Device Catalogue Number: 0010-6110
• Device Lot Number: 0023487677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1