MAUDE Adverse Event Report: GYRUS ACMI, INC 2.7MM LONG GYN TELESCOPE

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.

• 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 Key: 11421397
• MDR Text Key: 243034420
• Report Number: 1519132-2021-00006
• Device Sequence Number: 1
• Product Code: FHO
• UDI-Device Identifier: 00821925008427
• UDI-Public: 00821925008427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980972
• Number of Events Reported: 1
• 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

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G27L-30WA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1