MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA VIDEO SYSTEM CENTER

Model Number	OTV-S7V
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the video system center had poor quality video and the video image was interrupted.There were no reports of patient harm.
Additional Manufacturer Narrative
Correction to manufacturing site - medwatch sections d3 and g1b -shirakawa (3002808148).
Additional Manufacturer Narrative
Correction to e1 (telephone number) of the initial report.See e1 for further details.Update to b5 of the initial report.See b5 for further details.This supplemental report is being submitted to provide the results of the device evaluation and the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was returned to olympus and the allegation reported in b5 was confirmed.Based on the results of the investigation, corrosion was observed in the video connector contacts.It is likely that phenomenon ¿image is interrupted¿ occurred because electrical communication could not be performed properly due to contact failure caused by corrosion on the video connector contacts.However, a definitive root cause could not be identified.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The reported issue occurred during preparation for use for a stent replacement procedure.The procedure was completed with a similar device with no procedural delay.

• Brand Name: VISERA VIDEO SYSTEM CENTER
• Common Device Name: VIDEO SYSTEM CENTER
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; odakura, nishigo-mura, 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; odakura, nishigo-mura,
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19945455
• Report Number: 9610595-2024-15957
• Device Sequence Number: 8074782
• Product Code: FET
• UDI-Device Identifier: 04953170141546
• UDI-Public: 04953170141546
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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: OTV-S7V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/21/2024; 09/06/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2002
• 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