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

Model Number	WA03300A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus was informed that one day after a therapeutic transurethral resection in saline (turis) procedure a burn of approx 1.04 inches was discovered on the patien's thigh.A skin graft was performed at the location of the burn injury and the patient was discharged from hospital.
Additional Manufacturer Narrative
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, since there was no report of any defect or malfunction of the involved light-guide cable, it is assumed that the article is very likely in standard condition.Furthermore, a material or quality problem can be excluded since a manufacturing and quality control review was performed for the affected lot number of the ligh-guide cable without showing any abnormalities.The case will be closed on 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: LIGHTSOURCE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): SCHOTT; hattenbergstrasse 10; mainz 55122 ; GM 55122
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 16022547
• Report Number: 9610773-2022-00708
• Device Sequence Number: 5784708
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2022

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: 21XW0007
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED STORZ RESECTOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male