MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE; LIGHT GUIDE CABLE

Model Number	WA03300A
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of our investigation, multiple follow ups were made to the user facility in an attempt to gather additional information on the reported event; however, no additional information was obtained to date.In addition, the device was not returned to the service center for evaluation.Therefore, the cause of the reported event cannot be determined at this time.This reported event has been reported by the importer on mdr# 2951238-2020-00312.
Event or Problem Description
On december 17, 2019 the manufacturer received medwatch report (mw5091350) that states, "during cystoscopy procedure, room staff noted they smelled something burning and patient moaned in pain so cystoscopy scope was removed.The end of the scope was blackened and scope body also had lighter colored black marks on shaft.This scope was used with an olympus light cable and a karl storz light source." this report is for 2 of 2 devices.
Additional Manufacturer Narrative
The risk manager at the user facility further reported the diagnostic cystoscopy procedure was just at the point of completion when the injury was detected as the physician visualized injury through the scope at the end of the procedure.The injury was located on the patient's bladder wall.There was no treatment or longer stay required.The physician noted that the injury presented like a purposeful cauterization and that it would require no intervention to heal.There was no delay in the procedure.The devices were said to have been provided to vendor.The devices were inspected prior to procedure with no anomalies observed.
Additional Manufacturer Narrative
The original equipment manufacturer (oste) conducted a review of the device history records (dhr).The manufacturing and quality control review was performed for the affected lot without showing any non-conformities or deviations regarding the described issue.There was no non-conformities associated with this device with respect to the described issue.

• Brand Name: LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
• Common Device Name: LIGHT GUIDE CABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 9577977
• Report Number: 9610773-2020-00045
• Device Sequence Number: 16951318
• Product Code: HBI
• UDI-Device Identifier: 04042761082297
• UDI-Public: 04042761082297
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA03300A
• Device Catalogue Number: WA03300A
• Device Lot Number: 154W0001
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/17/2020; 03/25/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/06/2020; 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KARL STORZ 201336-20 SERIAL # (B)(4); KARL STORZ: 201336-20 S/N UNKNOWN; OLYMPUS M3 30A SERIAL # (B)(4); OLYMPUS: M3-30A S/N UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 104