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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC ROTATING CF RESECTOSCOPE INNER SHEATH
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GYRUS ACMI, INC ROTATING CF RESECTOSCOPE INNER SHEATH Back to Search Results
Model Number ERIS-CF25
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device is received and evaluated.The reported failure of broken ceramic tip was confirmed.The device was placed for repair.If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the device was found with broken ceramic tip.No further details were provided regarding the event.No patient involvement was reported.No user harm or injury was reported.
 
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Brand Name
ROTATING CF RESECTOSCOPE INNER SHEATH
Type of Device
ROTATING CF RESECTOSCOPE INNER SHEATH
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
Manufacturer Contact
kenneth pittman
93 north pleasant st.
norwalk, OH 44857
9013785969
MDR Report Key10439794
MDR Text Key205005919
Report Number1519132-2020-00058
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberERIS-CF25
Device Lot NumberFA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2020
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 Reuse
Patient Sequence Number1
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