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

Model Number	WA03310A
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Codes	Bowel Burn (1756); Injury (2348); No Information (3190)
Date of Event	06/24/2020
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 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 after a cholecystotomy procedure, a re-hospitalization and surgical resumption was required.It was reported that the practitioner suspects a material defect.Despite several efforts to date, no further information was provided so far.
Additional Manufacturer Narrative
Device evaluation: the suspect medical device was returned to the manufacturer for investigation.The investigation confirmed that the strain relieve of the cable unit is torn.A damaged strain relief led to the breakage of some fibers which resulted in reduced light transmission.Therefore, this event/incident was attributed to use error.However, the manufacturer cannot evaluate how this damage is related to reported re-hospitalization and surgical resumption since no further information was provided by the customer.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 cable unit without showing any abnormalities.The case will be closed from olympus side with no further actions but the reported event/incident will be recorded for trending and surveillance purposes.Furthermore, the user will be informed about the investigation results.
Event or Problem Description
Olympus was informed that after a cholecystotomy procedure, a re-hospitalization and surgical resumption was required.It was reported that the practitioner suspects a material defect.The patient suffered an injury and burn on the small intestine/bowel which consequently led to surgical recovery and hospitalization in intensive care unit.

• Brand Name: LIGHT-GUIDE CABLE, 4.25 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: 10395588
• Report Number: 9610773-2020-00187
• Device Sequence Number: 2767341
• Product Code: HBI
• UDI-Device Identifier: 04042761082303
• UDI-Public: 04042761082303
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA03310A
• Device Catalogue Number: WA03310A
• Device Lot Number: 164W002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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: Hospitalization