MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. WATER-RESISTANT CAP; WATER RESISTANT CAP

Model Number	MH-553
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
"the customer reported to olympus that during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) surgical procedure, water damage was found during use of the evis exera ii duodenovideoscope.The endoscope was inspected prior to use and the customer reported that water was inside the cap designed to protect the scope from water.The device was working when initial plugged in, however, the procedure was aborted due to the lack of visibility with the endoscope.No information was provided if the patient was under anesthesia and if the procedure was extended due to the event.The patient outcome is unknown.This complaint requires two reports: (b)(6): tjf-q180v.(b)(6): mh-553.This medwatch report is for patient identifier: (b)(6).
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Additional Manufacturer Narrative
Updated b5 to reflect additional information received.
Event or Problem Description
Olympus further received information that the image was lost after the procedure was commenced.The patient sustained no injuries and ended up having the procedure in a different hospital.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, since the device was not returned for an evaluation, the reported event could not be confirmed.Therefore, the root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: WATER-RESISTANT CAP
• Common Device Name: WATER RESISTANT CAP
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16616376
• Report Number: 9610595-2023-05042
• Device Sequence Number: 6272430
• Product Code: EOQ
• UDI-Device Identifier: 04953170286438
• UDI-Public: 04953170286438
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K963033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

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: MH-553
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/29/2023; 05/25/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/27/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TJF-Q180V: EVIS EXERA III DUODENOVIDEOSCOPE.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown