• 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 2.7MM LONG GYN TELESCOPE

  • 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 2.7MM LONG GYN TELESCOPE Back to Search Results
Model Number G27L-30WA
Device Problem Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was evaluated.Inspection of the device confirmed the reported issue.The device outer tube was observed to be bent at the proximal end.In addition, the objective cover glass was fractured with dents in the edge.Internal lenses were noted to be broken.Device history records were reviewed and showed the product met all specifications upon release.Based on device inspection results, physical damage found on the device was most likely due to user mishandling.To prevent inadvertent damage to the device, the device ifu (instruction for use) 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.
 
Event Description
It was reported that the device was found with a bent shaft.The issue occurred during reprocessing.There was no patient involvement on this event reported.No user injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2.7MM LONG GYN TELESCOPE
Type of Device
2.7MM LONG GYN TELESCOPE
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 Key11421397
MDR Text Key243034420
Report Number1519132-2021-00006
Device Sequence Number1
Product Code FHO
UDI-Device Identifier00821925008427
UDI-Public00821925008427
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 03/05/2021
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 NumberG27L-30WA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/10/2021
Initial Date FDA Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-