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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS CYSTOVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS CYSTOVIDEOSCOPE Back to Search Results
Model Number CYF-240
Device Problems Break (1069); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/17/2018
Event Type  malfunction  
Manufacturer Narrative
The fragment was not sent to olympus. The subject device in this report has not been returned to omsc for evaluation, but was returned to olympus (b)(4). (b)(4) confirmed the followings during inspecting the subject device. The subject device passed the air leakage testing at (b)(4). The adhesive of one of the two light guide lenses was completely missing. The adhesive of other light guide lenses was deteriorated and partially missing. No other than the above material or components were found to be missing from the subject device. There were cracks and chippings in the light guide lenses. Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity. Although (b)(4) has not received the fragment itself, it is surmised that the fragment found within the patient bladder was missing adhesive from the light guide lenses. The instruction has already warns and instructs; before each case, prepare and inspect this instrument as instructed below. Inspect other equipment used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see chapter 9, ¿troubleshooting¿. If the irregularity is still suspected after consulting chapter 9, contact olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage. If the endoscope is visibly damaged, does not function as expected or is found to have irregularities during the inspection described in chapter 3, ¿preparation and inspection¿, do not use the endoscope. Contact olympus. Some problems that appear to be malfunctions may be correctable by referring to section 9. 1, ¿troubleshooting guide¿. If the problem cannot be resolved by the described remedial action, stop using the endoscope and send it to olympus for repair. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that a black plastic fragment fell off from the distal end of the subject device within the patient¿s bladder during an unspecified diagnostic procedure. The procedure was prolonged in order to retrieve the fragment using a stent retriever from the patient. The procedure was completed and the patient was discharged from the user facility on the day the patient underwent the procedure. There was no report of injury associated with this report.
 
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Brand NameEVIS CYSTOVIDEOSCOPE
Type of DeviceCYSTOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-sho
hachioji-shi, hachioji-shi 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 Key8389204
MDR Text Key139439998
Report Number8010047-2019-01183
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K843084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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