MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SDI CABLE 8.5M

Model Number	MAJ-1912
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this event by the customer, the device broke and the pin came out.The cable was not being used at the time.There is no patient involvement and no harm reported to any patient.
Additional Manufacturer Narrative
The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, the customer stated he needed a part number for a longer cable and was provided part number hdvc-50-1 for the 50' sdi cable and then transferred to customer service to place the order.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to handling by the user might have contributed to the event.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that the sdi cable (maj-1912) cable broke and the pin came out.The cable was not being used at the time.There is no patient involvement and no harm reported to any patient.

• Brand Name: SDI CABLE 8.5M
• Common Device Name: SDI CABLE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14268775
• Report Number: 8010047-2022-07393
• Device Sequence Number: 4840864
• Product Code: FDF
• UDI-Device Identifier: 04953170304866
• UDI-Public: 04953170304866
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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
• Device Model Number: MAJ-1912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown