MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FUSE; ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT

Model Number	FSC-3300-ST
Medical Device Problem Codes	Leak/Splash (1354); Poor Quality Image (1408)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the device was received at the repair center.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a fuse 1c colonoscope was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, leaking was noted in the biopsy channel.The left and the right image was flickering.Another fuse 1c colonoscope was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the device was received at the repair center.Block h6: device code 1354 captures the reportable issue of leak at scope tip.Block h10: a fuse 1c colonoscope was received for analysis.A functional evaluation was performed and a leak was found in the biopsy channel.The reported right and left image flickering could not be replicated.The possible cause of the image issue was fluid invasion and no fluid was noted in ec at the time of inspection.The reported leak complaint was confirmed.However, the right and left image flickering complaint was not confirmed.The cause of reported leak failure is due to found leak in biopsy channel.Therefore, the assigned investigation conclusion code for this complaint is designated as cause traced to component failure.The repair history was reviewed and nothing was found to indicate a possible service-related cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a fuse 1c colonoscope was used during a colonoscopy procedure performed on an unknown date.According to the complainant, during the procedure, leaking was noted in the biopsy channel.The left and the right image was flickering.Another fuse 1c colonoscope was used to complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: FUSE
• Common Device Name: ENDOSCOPE, ACCESSORIES, IMAGE POST-PROCESSING FOR COLOR ENHANCEMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8138519
• Report Number: 3005099803-2018-61826
• Device Sequence Number: 216839
• Product Code: PEA
• UDI-Device Identifier: 00816849019666
• UDI-Public: 00816849019666
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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 Model Number: FSC-3300-ST
• Device Catalogue Number: 60093
• Device Lot Number: F1C0600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1