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

Model Number	FB-220U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597)
Date of Event	01/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to olympus for evaluation.The cause of the reported event could not be determined, however, the most likely cause of the patient's outcome is attributed to the operator¿s technique.The instruction manual contains several warning and caution statements in an 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.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.¿.
Event or Problem Description
Olympus was informed that during a colonoscopy procedure, the forcep was not grabbing the tissue properly causing the patient¿s mucosa to tear with moderate bleeding.The bleeding was treated by applying clips to the affected area.This resulted in a short delay.The intended procedure was completed with the same device.Additionally, the user facility reported that at no time was force applied to assist device operation.There were no issues inserting or withdrawing device from the patient.The device was inspected prior to use and there were no abnormalities.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the original equipment manufacturer.The original equipment manufacturer (oem) reviewed the content of this complaint and determined that the customer¿s concern could not be confirmed because the device was not returned to us.The exact cause of the phenomenon remains unknown as the event unit was not returned and could not be evaluated.Based on similar complaints, the reported phenomenon is considered to be a procedural accident due to a procedure or patient¿s condition.The oem recommends the user follow details that are found in the instruction manual.Please instruct the user on how to use this product if necessary.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.If you press the instrument¿s distal end too hard against the tissue in an attempt to take a sample more than needed, the risk of perforation increase.Do not take more than needed.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.A review of the dhr found no anomalies during the manufacturing of the subject device and lot number.

• 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: 8351520
• Report Number: 2951238-2019-00441
• Device Sequence Number: 16194593
• Product Code: FCL
• UDI-Device Identifier: 04953170031076
• UDI-Public: 04953170031076
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-220U
• Device Lot Number: 85V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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