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, Thermal (2530)
Date of Event	11/01/2018
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 user's experience 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), the patient sustained a burn on the inner thigh which required further treatment.No further information was provided and there was no report about a malfunction of any of the medical devices.The intended procedure was completed with the same set of equipment.
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the investigation/evaluation was performed exclusively on the basis of the information provided by the customer.There were no reports of any malfunction of the light-guide cable.Based on the information available, the exact cause of the reported phenomenon and the patient¿s outcome could not be determined and is being judged as unknown.Furthermore, a manufacturing and quality control review could not be performed since basic data of article identification (lot number) are missing.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.

• 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
• MDR Report Key: 8373476
• Report Number: 9610773-2019-00051
• Device Sequence Number: 19396571
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/08/2019
• 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: UNSPECIFIED THIRD PARTY MANUFACTURER LIGHT SOURCE; UNSPECIFIED THIRD PARTY MANUFACTURER TELESCOPE; UNSPECIFIED THIRD PARTY MANUFACTURER LIGHT SOURCE; UNSPECIFIED THIRD PARTY MANUFACTURER TELESCOPE
• Outcome Attributed to Adverse Event: Required Intervention