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

Model Number	FB-220U
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Alteration In Body Temperature (2682)
Date of Event	05/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.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 conclusively determined at this time.If additional information becomes available or the device is returned at a later date this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed that during an unspecified procedure, the needle from the forceps broke off and fell into the patient.The device fragment was retrieved.The intended procedure was completed with a similar device.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received from the user facility.Additional information received from the user facility states that the previously reported forcep damage occurred during a diagnostic esophagogastroduodenoscopy (egd) procedure.The doctor was retrieving a biopsy sample when the forceps broke.There was no unusual bleeding observed.There was no external force applied to the forceps during the procedure.No other equipment was replaced during the procedure.Additionally, the forceps were inspected prior to the procedure with no anomalies noted.Prior to the procedure the forceps were housed in the user facility¿s storage room.

• 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: 7934774
• Report Number: 2951238-2018-00603
• Device Sequence Number: 19182349
• Product Code: FCL
• UDI-Device Identifier: 04953170031076
• UDI-Public: 04953170031076
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K955065
• 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): 10/30/2018

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-220U
• Device Catalogue Number: FB-220U
• Device Lot Number: 81V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/04/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1