MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPE; LIGHT GUIDE AND ACCESSORIES

Model Number	WA03310A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/13/2020
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 during a therapeutic total laparoscopic hysterectomy (tlh) procedure the patient sustained a burn injury when the activated wa03310a light-guide cable was placed on the patient¿s abdomen with no telescope connected.No further information was provided but there was no report about a malfunction of the olympus medical devices.
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 conclusively determined and is being judged as unknown.However, since it is clearly stated as a caution note in the instructions for use that the connectors of the endoscopic equipment and the distal end of the endoscope become hot and that there is a risk of burns if the equipment is placed on the patient¿s skin, this incident was attributed to use error.Furthermore, a dhr review could not be performed since basic data of article identification (lot number) are missing.Instead a manufacturing and quality control review was performed for the last 24 months of production.There were no non-conformities or deviations regarding the described issue.The case will be closed on olympus side with no further actions.However, 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, 4.25 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: 10064336
• Report Number: 9610773-2020-00119
• Device Sequence Number: 10932224
• Product Code: HBI
• UDI-Device Identifier: 04042761082303
• UDI-Public: 04042761082303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: Health Professional
• Device Model Number: WA03310A
• Device Catalogue Number: WA03310A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/15/2020
• Initial Report FDA Received Date: 05/18/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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: OLYMPUS VISERA ELITE IIVIDEO SYSTEM OTV-S300
• Outcome Attributed to Adverse Event: Required Intervention