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

Model Number FB-244U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The forceps used in the procedure were not returned to olympus for evaluation.However, the customer did return two brand new boxes (total 32 pcs) of the model fb-244u forceps.A visual inspection was performed on four of the returned fb-244u forceps and no anomalies were noted.The forceps were looped 20cm from the distal end side and the device jaws were noted to extract normal as the base of the device was manipulated.The forceps were inserted inside the channel of a cf-hq190l test scope and looped the insertion tube about 20cm; the movement of the jaws again operated normally.The insertion portion was inspected and did not see any signs of kinks, cuts or damages.The slider was manipulated and the movement was consistent and smooth.The manipulation wires, needle, and cups were checked as well as the open and close movement with no issue.Since the customer did not return the used forceps the cause of the reported event cannot be conclusively determined.However, based on similar reports the user technique cannot be ruled out as a contributory factor.The instruction manual of the subject device provides several warnings to users in effort to mitigate 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 Description

Olympus was informed that the user facility¿s physicians reported feeling a tearing sensation when using the single use biopsy forceps, as a result 5 to 6 patients experienced excessive bleeding and hematomas.Clips were used to treat the bleeding and close the affected site.It is unknown if the intended procedures were completed.Additionally, it was reported that the clinicians were new to the use of this forcep, although a previous trial was completed.This is report 2 of 6.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the original equipment manufacturer (oem).The oem performed a review of the device history record (dhr) and found no anomalies during the manufacturing of the subject device and lot number.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the aware date (see section g4).

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Type of Device: DISPOSABLE 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: 7997568
• MDR Text Key: 124793370
• Report Number: 2951238-2018-00645
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 04953170304613
• UDI-Public: 04953170304613
• Combination Product (y/n): N
• PMA/PMN Number: K955065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FB-244U
• Device Lot Number: 85V31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other