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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 43CM

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GYRUS ACMI, INC URETEROSCOPE, 43CM Back to Search Results
Model Number MR-6LA
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation confirmed the reported failure. The distal tip was bent with knurled ring received. Image was out of center due to bent distal tube. Minor debris under e/p window was noted. Dhrs (device history records) for this product has been reviewed. The device was an rex scope manufactured on may 01, 2019. All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. Bent distal tip is a known phenomenon that is often incurred as a result of user mishandling. On page 8 of the device ifu (instruction for use), bent shaft is addressed, "undue stress on the endoscope shaft may cause bending or breaking. If the distal shaft is bent due to the rigors of a difficult procedure, do not attempt to straighten it; damage can result. " the iuf advises: "avoid using excessive torque/force on the endoscope, as patient injury and possible damage to the instrument could result. Olympus will continue to monitor complaints for this device.
 
Event Description
It was reported that the device distal tip was found bent, damaged, broken with a sharp edge. There were no further details provided regarding the reported event. No patient involvement reported. No user injury reported.
 
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Brand NameURETEROSCOPE, 43CM
Type of DeviceURETEROSCOPE, 43CM
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 Key11095822
MDR Text Key225522701
Report Number1519132-2020-00110
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 01/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2020
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 Manufacturer12/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2019
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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