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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. AUTOCLAVABLE CAMERA HEAD

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SHIRAKAWA OLYMPUS CO., LTD. AUTOCLAVABLE CAMERA HEAD Back to Search Results
Model Number OTV-S7H-NA-10E
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned for evaluation.The reported issue (part of image not displayed) was confirmed during testing; this was determined caused by a defective coupler unit.In addition to the partial loss of image, the following issues were identified: the coupler unit was corroded; one of the washer rings was deformed and dirty; a portion of the camera head could not be fully fixed back into place; screws can't be fixed with proper torque into the switch button stage, remote button 2 was non-functional; the connector cable had a pinhole; the remote buttons had sustained fluid ingression; and the ac plate was discolored.The investigation is ongoing.A supplemental report will be submitted upon completion of investigation.
 
Event Description
The customer reported the olympus autoclavable camera head caused the displayed image to partially disappear.The issue was identified during reprocessing.No adverse effects to patient were reported.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the phenomenon, "the image is cropped due to a defective coupler unit¿, was confirmed.Therefore, it was determined that the reportable phenomenon, "the image is not displayed at full", occurred due to a defective coupler unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.
 
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Brand Name
AUTOCLAVABLE CAMERA HEAD
Type of Device
CAMERA HEAD
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 Key17083939
MDR Text Key316797483
Report Number3002808148-2023-05713
Device Sequence Number1
Product Code IYO
UDI-Device Identifier04953170141805
UDI-Public04953170141805
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K043275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/01/2023
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
Device Operator Health Professional
Device Model NumberOTV-S7H-NA-10E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/11/2023
Initial Date FDA Received06/07/2023
Supplement Dates Manufacturer Received07/07/2023
Supplement Dates FDA Received08/02/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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