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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG

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OLYMPUS MEDICAL SYSTEMS CORP. FORCEPS/IRRIGATION PLUG (ISOLATED TYPE) FORCEPS/ IRRIGATION PLUG Back to Search Results
Model Number MAJ-891
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus (b)(4). (b)(4) checked the subject device and found that the reported phenomenon was duplicated. Omsc could not review the manufacturing history (dhr) of the subject device because the lot number of the subject device was unknown. The exact cause of the reported event could not be conclusively determined at this time. However, based upon the information from (b)(4) and similar past cases, omsc surmised that the reported phenomenon was caused by the deterioration and peeling of the adhesive between the metal parts and the plastic parts (black) due to physical stress, chemical stress, and so on. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user facility that during the reprocessing, it was found that the tightening ring of the subject device had separated with its internal metal parts and its outer plastic parts, and that the biopsy valve had been frequently clogged with the tightening rings. There was no report of patient injury associated with this event.
 
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Brand NameFORCEPS/IRRIGATION PLUG (ISOLATED TYPE)
Type of DeviceFORCEPS/ IRRIGATION PLUG
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key12702263
MDR Text Key282272504
Report Number8010047-2021-13687
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMAJ-891
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/21/2021
Is This a Reprocessed and Reused Single-Use Device? No

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