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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG CYSTOSCOPE

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GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG CYSTOSCOPE Back to Search Results
Model Number M3-70A
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. The user¿s complaint of damaged outer tube was confirmed. The device was inspected and found a broken e/p cup and chipped lenses in the optical system. No additional information was provided.

 
Event Description

The user facility reported that there was damage to the outer tube. The tube was bent around the lens area. The black part on the top of the scope has a crack in it. There was no patient involvement. No additional information was provided.

 
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Brand NameM3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG
Type of DeviceCYSTOSCOPE
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 Key10395616
MDR Text Key203529085
Report Number1519132-2020-00049
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK890328
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 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/12/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM3-70A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/02/2020
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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