MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FUSE FULL SPECTRUM ENDOSCOPY SYSTEM; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	FSG-2500-MC90
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A fuse 1g gastroscope was returned for analysis.A functional analysis was performed, and a leak was noted in the biopsy channel.The biopsy channel was replaced to resolve the issue.The reported leak is consistent with the passing of damaged or incorrect accessories through the biopsy channel, which could lead to a puncture of the channel and a resulting leak.Therefore, the most probable root cause for the reported leak is unintended use error caused or contributed to event.The reported patient infections are consistent with improper reprocessing of the scope which could cause or contribute to patient cross-contamination.Therefore, the most probable root cause for the reported patient infections is failure to follow instructions.A review of the device history record was performed, and nothing was found to indicate a possible service-related cause for the reported events.
Event or Problem Description
Note: this report pertains to one device that was used during five procedures on the same date.It was reported to boston scientific corporation that a fuse 1g gastroscope was used during five gastroscopy procedures performed on (b)(6) 2019.According to the complainant, each patient was tested for h.Pylori during the procedure.Lab analysis revealed that all five patients tested positive for h.Pylori.The physician prescribed each patient three dosages of antibiotics (unknown) to treat the infection.Reportedly, the gastroscope was not properly reprocessed and tested by the facility's reprocessing technician.The complainant suspected that the scope had a leak that was not detected due to the improper reprocessing.The complainant confirmed that one technician was involved in the event, and one gastroscope was affected.The technician was terminated, and the facility considers the investigation to be concluded.There is nothing in the complaint record to suggest an inadequacy of the device or the manufacturer's reprocessing directions.In addition, a boston scientific field engineer has contacted the facility regarding follow-up training on the scope reprocessing procedure.

• Brand Name: FUSE FULL SPECTRUM ENDOSCOPY SYSTEM
• Common Device Name: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8524645
• Report Number: 3005099803-2019-01999
• Device Sequence Number: 15974858
• Product Code: FDS
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FSG-2500-MC90
• Device Catalogue Number: 60094
• Device Lot Number: 0001400407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR