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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 09/24/2021
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed by the user that during reprocessing, it was found that there were debris around the irrigation port, and the forceps/irrigation plug maj-891 could not withstand the reprocessing process. Due to a defect, the user reprocessed the forceps/irrigation plug maj-891 with sterrad gas plasma sterilization only on (b)(6) 2021. Prior to that, the forceps/irrigation plug maj-891 was steam sterilized. The forceps/irrigation plug maj-891 is not compatible with sterrad gas plasma sterilization. In addition, the user reported that only two months had passed since the forceps/irrigation plug maj-891 was purchased. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The device was not returned to any of olympus locations. Therefore, olympus could not investigate the device. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
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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 Key12686965
MDR Text Key281097108
Report Number8010047-2021-13561
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
Type of Report Initial
Report Date 10/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAJ-891
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

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