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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 33CM RIGID / SEMI RIGID SCOPES

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GYRUS ACMI, INC URETEROSCOPE, 33CM RIGID / SEMI RIGID SCOPES Back to Search Results
Model Number MR-6A
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to the service center for evaluation. Upon inspection of the returned device, the user report was confirmed, finding the distal end was damaged and dented. Minor dents in e/p edge and slightly cloudy image were also noted. The investigation is ongoing. If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the device distal tip is damaged, broken with a sharp edge. There was no patient involvement reported on this event. No user injury reported.
 
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Brand NameURETEROSCOPE, 33CM
Type of DeviceRIGID / SEMI RIGID SCOPES
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 Key11371822
MDR Text Key244695000
Report Number1519132-2021-00005
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052044
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMR-6A
Device Catalogue NumberMR-6A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2020
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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