MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. 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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus technical assistance center (tac), the serial digital interface (sdi) cable 8.5m was noted to be damaged.It was noted that the sdi cable fell from the ceiling and the tip broke off.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The subject device has not been returned to olympus for evaluation.During troubleshooting, the customer was provided with part number for replacement of the sdi cable.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and corrections to b5 and d4.Please see updates to b5, d4, h6 and h10.Three attempts were performed to obtain additional information, but no response was received from the customer.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.The cable was discarded by the customer.Based on the results of the investigation, it¿s likely the damaged sdi cable was due to external forces.The final root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that an employee tripped on the cable and it dislodged from the portable monitor.The event did not occur during a procedure and there was no patient involvement.

• Brand Name: SDI CABLE 8.5M
• Common Device Name: SDI CABLE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17143015
• Report Number: 3002808148-2023-06055
• Device Sequence Number: 7802413
• Product Code: FDF
• UDI-Device Identifier: 04953170304866
• UDI-Public: 04953170304866
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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-1912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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