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

Model Number	FB-231K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
The following events regarding postoperative bleeding after biopsy were reported in the 95th congress of the (b)(6) gastroenterological endoscopy society.Article title: clinical study of bleeding of patients under antithrombotic treatment after endoscopic biopsy for upper gastrointestinal tract the total cases were 33,295.They were performed from march 2011 to february 2017.Fb-231ks were used for upper endoscopic examinations.One week later after the examination, the doctor asked all patients whether bleeding occurred.In the study, accidental bleeding of 4 cases occurred after gastric biopsy as follows.Group of non-taking antithrombotic medicine: 2 cases group of taking antiplatelet agent: 1 case group of taking anticoagulant agent: 1 case all cases were treated endoscopically.The malfunction of fb-231ks was not reported.This report is regarding 4 of 4 accidental bleeding cases.
Additional Manufacturer Narrative
This supplemental report is submitting to correct "device product code".

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7559460
• Report Number: 8010047-2018-00974
• Device Sequence Number: 13508607
• Product Code: FCL
• UDI-Device Identifier: 04953170389511
• UDI-Public: 04953170389511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: FB-231K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 03/06/2019
• 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: Required Intervention