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

Model Number	FB-56D-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature title "steep infundibulopelvic angle as a new risk factor for flexible ureteroscope damage and complicated postoperative course." the literature reported the result of 381 cases of the flexible ureteroscopy (furs) procedures using an olympus model urf-v (ureteroscope) and fb-56d-1 (biopsy forceps) between september 2013 and march 2017.In the subject procedures, the following cases reportedly occurred.4 bleeding complication cases.27 urinary tract infection cases.5 perforation cases of the upper urinary tract.2 pneumonia cases.2 unknown complications.Based on the available information, a direct relationship between the subject devices and the observed reported adverse events could not be determined.According to the number of accidental symptoms and the number of olympus devices used for the procedures, omsc is submitting 10 medical device reports.This report is 4th of 10 reports for perforation of the upper urinary tract and fb-56d-1.

• 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: 9726301
• Report Number: 8010047-2020-01440
• Device Sequence Number: 2475017
• Product Code: GCJ
• UDI-Device Identifier: 04953170048821
• UDI-Public: 04953170048821
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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?: No
• Operator of Device: No Information
• Device Model Number: FB-56D-1
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1