Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG; HYSTEROSCOPE (AND ACCESSORIES)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number M3-0A
Device Problem Fogging (1253)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.The device was visually inspected and the outer tube was found to be bent and there was excessive debris underneath the glass cover on the distal tip.If additional information becomes available at a later time, this report will be supplemented.
 
Event Description
It was reported that the telescope image was foggy.There was no patient injury reported.
 
Manufacturer Narrative
This report is being supplemented to provide additional information (h6, h10) regarding the reported event.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.
 
Manufacturer Narrative
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG
Type of Device
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key10348316
MDR Text Key208335744
Report Number1519132-2020-00036
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,user f
Type of Report Initial,Followup,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3-0A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-