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

Model Number FB-230K

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

The subject device referenced in this report was not 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 Description

During a gastric fundic biopsy, the subject device was used.The tissue was torn and a large sample was taken off.As a result, significant bleeding occurred.Clips were used for hemostasis.The intended procedure was completed with another device.No patient injury was reported.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There was no abnormality found with the subject device.The manufacturing record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.The device handling that may result in tissue damage and significant bleeding has been warned in the instruction manual 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
• 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: 9514585
• MDR Text Key: 185573934
• Report Number: 8010047-2019-04588
• Device Sequence Number: 1
• Product Code: FCL
• Combination Product (y/n): N
• PMA/PMN Number: CLASS1-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB-230K
• Device Lot Number: 95V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1