MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG

Model Number M3-30A

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation, however, the device evaluation, investigation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an unspecified procedure the distal end of the scope device was found burnt by cautery.There were no further details reported due to the event.No known patient harm, or injury reported.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number, customer response, updates 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.Physical evaluation of the subject device confirmed that the distal end was damaged with broken objective cover glass.It was unable to confirm whether the distal end was burnt or not.Dents in the outer tube and foggy image were also observed.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.

Event Description

Updates on event reported: the procedure was not completed with another device.No further information in regards to the procedure completion was provided.The name of the procedure being performed was a cystoscopy with cautery.The procedure was therapeutic.There was no delay in the procedure.

• 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 Key: 11027058
• MDR Text Key: 223153576
• Report Number: 1519132-2020-00107
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1