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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
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GYRUS ACMI, INC GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE Back to Search Results
Model Number G27L-12A
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was evaluated.Inspection of the device confirmed the reported issue.Device was found with fractured internal lens.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the device was found with fractured internal lens.The issue occurred during reprocessing.There was no patient involvement on this event reported.No user injury reported.
 
Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
Type of Device
GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key11261542
MDR Text Key232362008
Report Number1519132-2021-00003
Device Sequence Number1
Product Code FHO
UDI-Device Identifier00821925008915
UDI-Public00821925008915
Combination Product (y/n)N
PMA/PMN Number
K980972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG27L-12A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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