MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE HOT BIOPSY FORCEPS

Model Number	FD-210U
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The service center was informed that the during the procedure two devices of the same lot did not work properly.The device contact was reported to be intermittent which caused a delay of treatment resulting in excessive bleeding.A clip was used to control the bleeding and complete the procedure.Additional information has been requested, but is not available at the time of this report.This report is for device 2 of 2.

• Brand Name: DISPOSABLE HOT BIOPSY FORCEPS
• Common Device Name: DISPOSABLE HOT BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8884631
• Report Number: 2951238-2019-01055
• Device Sequence Number: 2548353
• Product Code: KGE
• UDI-Device Identifier: 04953170158759
• UDI-Public: 04953170158759
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2019
• Report Date (Section F): 08/12/2019

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: FD-210U
• Device Lot Number: 8YV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/17/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2019
• 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: Other
• Date Report Sent to FDA: 08/12/2019