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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 43CM URETEROSCOPE, ACCESSORIES, FLEXIBLE/RIGID

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GYRUS ACMI, INC URETEROSCOPE, 43CM URETEROSCOPE, ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Model Number MR-6LA
Device Problem Fogging (1253)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Based on the evaluation of the device, the customer¿s complaint of ¿blurry image¿ was confirmed. The image problem was attributed to a damaged distal tip. There was moisture observed underneath the cover glass, fiber breakage, and corroded objective window. 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 device was returned for service due to a blurry image. It was reported that this was observed during a preparation for use. There was no patient injury reported.
 
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Brand NameURETEROSCOPE, 43CM
Type of DeviceURETEROSCOPE, ACCESSORIES, FLEXIBLE/RIGID
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 Key10376998
MDR Text Key202553694
Report Number1519132-2020-00044
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 other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMR-6LA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/16/2020
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

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