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

Model Number	FB-24U-1
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined at this time.However, based on similar reports, the user technique cannot be ruled out as a contributory factory.The instruction manual warns users to ¿before each case, prepare and inspect the instrument as instructed below.Inspect other equipment to be used with the instrument as instructed in their respective instruction manuals.Should the slightest irregularity be suspected, do not use the instrument; contact olympus.Damage or irregularity may compromise patient or user safety, such as infection control risk, tissue irritation, perforation, bleeding or mucous membrane damage and may result in more-severe equipment damage.¿.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the forcep kept taking off the patient¿s mucous membrane.The intended was not completed.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received.Additional information was received from the user facility that states the doctor was unable to grab the patient¿s tissue with the forcep and no injury occurred.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results.The customer returned the fb-24u-1 biopsy forceps (lot k8206-1797) for evaluation.A visual inspection was performed on the received device and found the needle at the distal tip, badly bent.The damage to the needle at the distal tip is not allowing the forcep cups to fully close when manipulating the slider handle, which was apparent when attempting to grasp the latex sheet.The forcep cups not being able to fully close, might likely cause issues when attempting to collect tissue, since the cups are used for collecting per the instructions for use (ifu).The slider handle movement was also tested, which is normal and was tested by forming a loop on the insertion portion approximately 20 cm in diameter.The ring, slider, handle and insertion portion (up until the cups) have minor wear; and the lot number is clearly visible on the handle section.The forceps cap was not received with the device.The ifu (instructions for use) states the following, "when using an instrument with a needle, push the slider to open the cups and confirm that the needle is not detached or bent conspicuously." based on the evaluation, the likely cause of the bent needle at the distal end of the device is due to mishandling.In turn, the damaged needle is not allowing the forcep cups to close, and might cause issues when grasping.

• Brand Name: BIOPSY FORCEPS
• Common Device Name: 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: 8584930
• Report Number: 2951238-2019-00808
• Device Sequence Number: 13886078
• Product Code: EOQ
• UDI-Device Identifier: 04953170029974
• UDI-Public: 04953170029974
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K962555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-24U-1
• Device Lot Number: 82K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 12/12/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/06/2019; 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1