MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DIGTAL LIGHT SOURCE CABLE; DIGITAL LIGHT SOURCE CABLE

Model Number	MAJ-1933
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an unspecified procedure, the subject device was used with an evis lucera elite xenon light source olympus clv-290sl and evis lucera elite video system center olympus cv-290.In the procedure, the clv-290sl was turned off twice.At the first time the clv-290sl was turned off, a warning message with instructions on how to clean it was displayed.At the second time the clv-290sl was turned off, the patient was having a bleed.The intended procedure was cancelled.There was no patient injury reported.However, the patient had to be transferred to another endoscopic room while the failure phenomenon occurred.As an evaluation result by an olympus local service engineer after the event, there was no fault was found with the clv-290sl and the cv-290 and it was identified that the fault is with the subject device.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.The device history record was reviewed and found no irregularities.Omsc determined that the reported turn-off failure was attributed to malfunction of the subject device, based on the evaluation result of the subject device by an olympus local service engineer.However, the root cause of malfunction of the subject device could not be conclusively determined.

• Brand Name: DIGTAL LIGHT SOURCE CABLE
• Common Device Name: DIGITAL LIGHT SOURCE CABLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8973420
• Report Number: 8010047-2019-03220
• Device Sequence Number: 19656919
• Product Code: FDF
• UDI-Device Identifier: 04953170304972
• UDI-Public: 04953170304972
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MAJ-1933
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/08/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1