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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; HYSTEROSCOPE (AND ACCESSORIES)
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GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number M3-30A
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned for evaluation.The device was visually inspected and the internal lens was found to be fractured resulting in no image.Scratches on the eye cup were also identified.Additionally, scratches were found on the outer tube which has been determined to be a reportable malfunction.The cause cannot be conclusively determined.
 
Event Description
It was reported that during preparation for use there was no image from the device.
 
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Brand Name
M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
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 Key10099708
MDR Text Key208223786
Report Number1519132-2020-00003
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K890328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3-30A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/05/2020
Initial Date FDA Received05/28/2020
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
Patient Sequence Number1
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