MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE DISTAL ATTACHMENT

Model Number	D-201-10704
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed of the customer's event via mw5107777.The customer reported, during an unknown procedure, the distal attachment attached to the endoscope was seen in the patient's stomach.It was retrieved with a roth net.The distal attachment was inspected prior to use and no issues were found.The distal attachment was inspected after removal from the patient and found to be cut in half.A request for additional information is in progress.Update: this event includes 2 complaints: (b)(6)- distal cap.(b)(6)- unknown egd scope/gm-418500, (b)(6) 2022.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Common Device Name: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 14188968
• Report Number: 2951238-2022-00385
• Device Sequence Number: 17192139
• Product Code: FDS
• UDI-Device Identifier: 04953170278266
• UDI-Public: 04953170278266
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/22/2022
• Report Date (Section F): 03/25/2022

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: D-201-10704
• Device Lot Number: 19K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN OLYMPUS ENDOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown