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

Model Number	FD-210U
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The referenced device was retuned to the manufacturer for evaluation.A visual inspection was performed.The wires of the jaw were manipulated and the movement was normal as the jaws were opening and closing properly.Dental dam was used to test the integrity of the jaws and noted the clamping of the jaws was functioning normal.The insertion portion was checked and did not find any signs of kinks, dents, or external damages.The slider was manipulated and the movement is consistent and smooth.The plug was observed and no external damage was found.The plug was connected to a usg-400/esg-400 test generator and observed energy flowing normal.Based on the evaluation, the service center was not able to confirm the user¿s complaint as the forceps operate and function as intended with no signs of abnormalities.
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.The device malfunction was reported to have caused a delay of treatment resulting in excessive bleeding.Additional information has been requested, but is not available at the time of this report.This report is for device 1 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: 8884486
• Report Number: 8010047-2019-02934
• Device Sequence Number: 2549052
• Product Code: KGE
• UDI-Device Identifier: 04953170158759
• UDI-Public: 04953170158759
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• 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