MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCA; ENDOSCOPE CHANNEL ACCESSORY

Model Number	SUV-633
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 seal biopsy valve was used during a colonoscopy procedure performed on (b)(6) 2020.According to the complainant, it was noted that a piece of the biopsy cap was missing.The procedure was completed using the original seal biopsy valve.Reportedly, the missing piece was found during scope cleaning and was removed using a brush.There was no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code 1261 captures the reportable event of device material fragmentation.Block h10: a small fragmen of the seal biopsy valve was returned; however, the rest of the device was not returned for analysis.It is assumed that the returned fragment is the piece that was reportedly found in the scope after the procedure.Based on the available information and reported event, it is likely that handling and device conditions during procedure may have contributed to this event.The adverse event occurred during the procedure and the device had no influence on the event; therefore, the most probable cause of the reported event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a colonscopy procedure performed on (b)(6) 2020.According to the complainant, it was noted that a piece of the biopsy cap was missing.The procedure was completed using the orignal seal biopsy valve.Reportedly, the missing piece was found during scope cleaning and was removed using a brush.There was no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: ORCA
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10295142
• Report Number: 3005099803-2020-02833
• Device Sequence Number: 19441095
• Product Code: ODC
• UDI-Device Identifier: 08714729991144
• UDI-Public: 08714729991144
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: 12/11/2022
• Device Model Number: SUV-633
• Device Catalogue Number: 2219-04
• Device Lot Number: 0024919477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1