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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HD AUTOCLAVABLE CAMERA HEAD
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SHIRAKAWA OLYMPUS CO., LTD. HD AUTOCLAVABLE CAMERA HEAD Back to Search Results
Model Number OTV-S7PROH-HD-12E
Medical Device Problem Codes Leak/Splash (1354); Poor Quality Image (1408); Output Problem (3005)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/12/2026
Type of Reportable Event Malfunction
Event or Problem Description
The customer returned the camera head, which is an olympus asset with no reported complaint.During the evaluation of the device, image anomaly, leakage test failed and operation failure was found.Was observed.There was no patient involvement.
 
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Brand Name
HD AUTOCLAVABLE CAMERA HEAD
Common Device Name
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 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
+1(508)207-7661
MDR Report Key50181574
Report Number3002808148-2026-27452
Device Sequence Number18613585
Product Code FET
UDI-Device Identifier04953170228834
UDI-Public04953170228834
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K955404
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Foreign,Company Representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/07/2026
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 Other
Device Model NumberOTV-S7PROH-HD-12E
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/13/2026
Is the Reporter a Health Professional? No
Initial Date Received by Manufacturer 07/29/2026
Initial Report FDA Received Date08/07/2026
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured06/15/2015
Is the Device Labeled for Single Use? (Y/N) No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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