MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. BIOPSY VALVE

Model Number	MB-358
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The biopsy valve mb-358 was returned to olympus medical systems corp.(omsc) for evaluation.A picture showing the fragment fell off into the patient and the chipped biopsy valve suggests that the fragment is most likely to come from the product.Fracture surface analysis shows that excessive impact may have caused the chipping valve and the fragment then came off.The instruction manual of the device states the corresponding method in case of an abnormality.
Event or Problem Description
During the hemostasis of the endoscopic mucosal resection with the biopsy valve mb-358 and cf-h290i, a therapeutic product didn't pass through the instrument channel of the cf-h290i.When the customer inserted a cleaning brush into the channel of cf-h290i, a fragment of the biopsy valve came out of the channel and fell off into the patient's body.Based on x-ray, the user decided not to retrieve the fragment and to let it go out of the body naturally.There was no report of the patient injury.This is a report for the the biopsy valve mb-358.

• Brand Name: BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10506723
• Report Number: 8010047-2020-06326
• Device Sequence Number: 16448394
• Product Code: FDS
• UDI-Device Identifier: 04953170063947
• UDI-Public: 04953170063947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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 Model Number: MB-358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1