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

Model Number	FB-230U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device referenced in this report has not yet been 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
During a colonic biopsy, the subject device was used.It was reported that the device damaged tissue and the patient had a bleeding.No further information was provided.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, the cause of the reported event can likely be attributed to a procedural accident caused by the condition of the patient or mishandling of the device such as over-pressing of the cups against tissue.The instruction manual of the device has already warned as follows; do not force the distal end of the insertion portion against body cavity tissue.Doing so could cause patient injury, such as perforation, bleeding, or mucous membrane damage.Biopsy may cause bleeding.If you take a large sample or press the instrument¿s distal end against tissue excessively, the risk of bleeding will increase.Perform biopsy on minimum necessary spots only.

• 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: 8194740
• Report Number: 8010047-2018-02550
• Device Sequence Number: 19295347
• Product Code: FCL
• UDI-Device Identifier: 04953170354137
• UDI-Public: 04953170354137
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019

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-230U
• Device Lot Number: 83V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/25/2018
• Supplement Report FDA Received Date: 02/06/2019
• 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: Other