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

Model Number	FB-225U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The cause of the reported event cannot be determined at this time.However, based on the similar reports, the damage of the mucosa or bleeding can most likely be attributed to the user¿s technique or the condition of the patient.The instruction manual of the subject device provides several warnings to users in effort to prevent patient injury.¿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.Do not take more than needed.Perform biopsy on minimum necessary spots only.¿.
Event or Problem Description
The user facility informed olympus that patients are experiencing excessive bleeding after undergoing procedures with the single use biopsy forceps.It is not known how the bleeding was resolved or if the intended procedures were completed.Additionally, the user facility reported that although there was no issues noted with the device during use it cannot be ruled out as a contributing factor.This is report 2 of 2.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the original equipment manufacturer (oem).The oem reported that the exact cause of the phenomenon remains unknown as the event unit was not returned and could not be evaluated.However, based on similar reports, 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 oem also, performed a device history review for the models: fb-224u & fb-225u with lot number 77k through 87k and there were no nonconformities noted during the manufacturing of this device.

• Brand Name: SINGLE USE 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: 7716671
• Report Number: 2951238-2018-00427
• Device Sequence Number: 11080050
• Product Code: FCL
• UDI-Device Identifier: 04953170398858
• UDI-Public: 04953170398858
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXMPT
• 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,Followup
• Report Date (Section B): 10/23/2018

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-225U
• Device Catalogue Number: FB-225U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FB-224U/LOT#
• Outcome Attributed to Adverse Event: Other