MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. AUTOCLAVABLE CAMERA HEAD

Model Number	OTV-S7H-NA-10E
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus (omsc) was informed that the customer autoclavable camera head was returned to olympus for repair for a reported ¿disconnection of the connector connection¿.The reported problem was found during an unspecified event.No death, injury or harm was reported.
Additional Manufacturer Narrative
The referenced device was returned for evaluation.The customer¿s reported issue could not be confirmed/duplicated.A visual inspection found buckles/twists in the cabling.The camera head unit is heavily corroded internally.The internal head unit is discolored and the switch unit does not function.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.
Event or Problem Description
Additional information was received from the initial reporter noting the event (disconnection of the connector connection) occurred prior to use.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to b3, b5, h4 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the reported event (disconnection of the connector connection) was unable to be duplicated.The root cause of this event was unable to be identified.Additionally, the following was found during evaluation: kinks on the cable, imaging deterioration, switch does not work, and head of cable immersed in water.These defects are not considered severe enough to cause a potential adverse event.Olympus will continue to monitor field performance for this device.Correction to h6 - investigation findings of the initial medwatch.Upon completion of the legal manufacturers investigation, the investigation findings code should be 213-no device problem found.

• Brand Name: AUTOCLAVABLE CAMERA HEAD
• Common Device Name: CAMERA HEAD
• 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: 14836949
• Report Number: 8010047-2022-10880
• Device Sequence Number: 14048469
• Product Code: GCJ
• UDI-Device Identifier: 04953170141805
• UDI-Public: 04953170141805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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
• Operator of Device: Health Professional
• Device Model Number: OTV-S7H-NA-10E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2008
• 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