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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 Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 10/20/2020
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated. Device return evaluation confirmed the reported issue as the beak was found to be missing. No other defects were noted. Based on evaluation findings the reported failure was confirmed. Probable cause could be attributed to users handling of the device.
 
Event Description
It was reported that after a therapeutic greenlight laser vaporization procedure, prior to reprocessing, the device tip was found damaged and fell off. It is believed that the damage was caused by the greenlight laser light hitting the tip. There was no patient harm or injury reported due to the event. No user injury reported.
 
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Brand NameROTATING CF RESECTOSCOPE INNER SHEATH
Type of DeviceROTATING 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 Key10862838
MDR Text Key223460967
Report Number1519132-2020-00099
Device Sequence Number1
Product Code KNS
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 Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberERIS-CF25
Device Lot NumberHC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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