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

Model Number	WA03300A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient¿s outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that when the drape was removed from the patient after a successfully completed therapeutic transurethral lithotripsy (tul) procedure, it was noticed that the patient had sustained a burn injury of approx.22.5-23.5 mm on one leg.It is assumed that the burn occurred when the light-guide cable was shortly placed on the patient after it had been removed from the scope.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, in the case at hand, there was no report of a malfunction of the affected device and, therefore, it can be assumed that the light-guide cable was in standard condition and the burn injury most likely resulted from the user placing the cable on the patient's leg after disconnecting it from the telescope.When the cable is used in a procedure, heat builds up in the cable.This is clearly stated as a warning in the instructions for use.However, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the light-guide cable without showing any abnormalities.The case will be closed from olympus side with no further actions.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
• Common Device Name: LIGHT GUIDE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11371886
• Report Number: 9610773-2021-00081
• Device Sequence Number: 17071495
• Product Code: HBI
• UDI-Device Identifier: 04042761082297
• UDI-Public: 04042761082297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: Health Professional
• Device Model Number: WA03300A
• Device Catalogue Number: WA03300A
• Device Lot Number: 201W0001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention