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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 Consequences Or Impact To Patient (2199)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
The customer returned the maj-981 forceps/irrigation plug (lot 04a) to olympus for evaluation. A visual inspection was performed on the device as received, and the outer black plastic piece of the tightening ring was missing from the device. The missing piece of the tightening ring was not returned for evaluation. There was no other damages on the device, and the device securely attached to the cyf-v2r test video scope by way of the locking ring. Estimation attempted to remove the tightening ring with pliers while using extra caution to not damage the part, but was unsuccessful of freeing the tightening ring from the device. Based on the investigation, the adhesive that fixed the cover of the tightening ring broke. The stacking of the tightening ring caused torque to be applied to the bond via the tightening ring cover. The possible causes of the tightening ring stacking are as follows: when the user installed the maj-891, the tightening ring was tightened too much. When the user assembles maj-891, foreign matter was mixed in the screw part. This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes. A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
 
Event Description
The customer contacted olympus to report a device malfunction. Upon taking the new device out of its packing and attaching it to the scope, the device became stuck and could not be disassembled. The customer soaked the device in lubricant. After being taken out of the lubricant and upon disassembly, the black portion fell off the metal part. There was no patient injury or involvement. The intended procedure was completed using another device.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key11006516
MDR Text Key221554415
Report Number8010047-2020-10330
Device Sequence Number1
Product Code FGB
UDI-Device Identifier04953170063114
UDI-Public04953170063114
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMAJ-891
Device Lot Number04A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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