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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-FD
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
E1- facility name: (b)(6).E1- postal code: (b)(6).The evaluation of the event is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
 
Event Description
It was reported the camera head had a violet picture during holmium laser enucleation of the prostate procedure.The procedure took 30 minutes longer due to the issue.There were no reports of patient injury.
 
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Brand Name
HD 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 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19146764
MDR Text Key340677593
Report Number3002808148-2024-32334
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOTV-S7PROH-FD
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
LASER SURGERY UNIT (STARMEDTEC ); VIDEO PROCESSOR CV-190 (SN:(B)(6))
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