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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

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GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG Back to Search Results
Model Number M3-30A
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated.Evaluation determined that the device outer tube was found crushed.Dents in outer tube were observed.Debris on the optical system was determined causing blurry image.The ep/window, funnel cup were found fractured.The identified parts need to be replaced.Device was placed for repair.Based on evaluation findings the reported issue was confirmed.Probable root cause could be due to users handling and or maintenance issue.
 
Event Description
It was reported that during reprocessing the device outer tube was found crushed.There was no patient involvement on this reported event.No user injury reported.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the review of the device history records (dhr) and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the device evaluation results, damages found on the device could result from physical impact having occurred to the device, caused by user mishandling.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.Olympus will continue to monitor complaints for this device.
 
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Brand Name
M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
Type of Device
M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough MA 01772
MDR Report Key10804813
MDR Text Key217155876
Report Number1519132-2020-00096
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 12/14/2020
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 Manufacturer10/14/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/14/2020
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer Received11/15/2020
Supplement Dates FDA Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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