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

Model Number	0010-0622
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) confirmed that the devices met all material, assembly and performance specification.Analysis of the device revealed the total length of the fiber was 11 feet 6 inches and the distal end of the glass fiber is fractured.Based on the information available, an evaluation conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that during a procedure the physician noticed the tip flare from the fiber was poor.The performance was poor but enough to complete the case with no clinical consequences to the patient.The fiber was returned and analysis found that the distal end of the glass fiber was fractured.

• 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: 10445634
• Report Number: 2937094-2020-00773
• Device Sequence Number: 2452644
• Product Code: GEX
• UDI-Device Identifier: 00878953000107
• UDI-Public: 00878953000107
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K924644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: 12/06/2021
• Device Model Number: 0010-0622
• Device Catalogue Number: 0010-0622
• Device Lot Number: 0023043569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1