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

Model Number	0010-0632
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the fiber detached from the white adapter when the surgeon fired the laser.The procedure was completed with a second fiber and no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device was received in two pieces.Visual inspection noted the connector and fiber body were separated.Under magnification, the proximal end of the fiber body appeared to be fractured.It is likely the fiber was damaged due to rough handling of the device during set-up, which is warned against in the ifu.Therefore, an evaluation conclusion code of unintended use error caused or contributed to event was assigned.
Event or Problem Description
It was reported that during a procedure the fiber detached from the white adapter when the surgeon fired the laser.The procedure was completed with a second fiber and no clinical consequences to the patient.

• Brand Name: ENDOSTAT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10930506
• Report Number: 2937094-2020-01025
• Device Sequence Number: 909759
• Product Code: GEX
• UDI-Device Identifier: 00878953000060
• UDI-Public: 00878953000060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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: 07/19/2021
• Device Model Number: 0010-0632
• Device Catalogue Number: 0010-0632
• Device Lot Number: 0022399664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1