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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG; ADULT RESECTOSCOPE
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GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG; ADULT RESECTOSCOPE Back to Search Results
Model Number M3-12A
Device Problems No Display/Image (1183); Poor Quality Image (1408)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated.Evaluation found that the device optical fiber was observed with broken lens.The objective window was found with a dent.This resulted in the user reported blurry image.The identified parts need to be replaced.
 
Event Description
It was reported that the device was found with blurry picture.No further details were provided regarding the event.There was no patient involvement on this report.
 
Manufacturer Narrative
This supplemental is to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG
Type of Device
ADULT RESECTOSCOPE
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key10437189
MDR Text Key204025904
Report Number1519132-2020-00057
Device Sequence Number1
Product Code HIH
Combination Product (y/n)N
PMA/PMN Number
K890328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberM3-12A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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