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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OCS-500 (D) SET; COLPOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. OCS-500 (D) SET; COLPOSCOPE Back to Search Results
Model Number OCS-500
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned for investigation.Upon evaluation of the device, the reported issue of green filter broken was confirmed.Faulty mechanical parts such as green filter, eye piece, zoom changer and stopper screws were noted and required replacement.In addition, missing screws and dirt on the optical system were observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
 
Event Description
A user facility reported to olympus that the ocs-500 colposcope green filter is broken and required replacement.During a standard service inspection of the customer returned device, it was discovered that the eye piece performance was slow and the zoom change function had a broken gear.This report is to capture the zoom microscope body disconnecting from balancearm / fall of zoom microscope body reportable malfunction noted at estimation.There was no patient injury or harm reported.
 
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Brand Name
OCS-500 (D) SET
Type of Device
COLPOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12108826
MDR Text Key280750660
Report Number8010047-2021-08344
Device Sequence Number1
Product Code HEX
Combination Product (y/n)N
PMA/PMN Number
K852980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOCS-500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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