MAUDE Adverse Event Report: GYRUS ACMI, INC REPAIR SCOPE AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number REXM3-30A

Device Problems Thermal Decomposition of Device (1071); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.The complaint of burned tip was confirmed.In addition, chipped lens was observed.Device history record was reviewed and showed the product met all specifications upon release.Based on the investigation, the damage which occurred was likely due to use mishandling.However, the root cause of the reported event could not be conclusively specified.The reported failure is a known phenomenon.The device instructions for use (ifu_99-1080_bg) states: "if the white areas are not approximately equal, or are interspersed with large dark areas, the light carriers may be damaged.Check the distal tip for burns." (inspection, page 10); "keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active." (warnings, page 4) olympus will continue to monitor complaints for this device.

Event Description

It was reported " tip burnt at the end of scope".The issue found at reprocessing.There was no patient harm, no user injury reported due to the event.

• Brand Name: REPAIR SCOPE AUTOCLAVABLE
• Type of Device: RIGID ENDOSCOPE TELESCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 93 north pleasant st.; norwalk, OH 44857 ; 5082077661
• MDR Report Key: 15705303
• MDR Text Key: 302752158
• Report Number: 1519132-2022-00020
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925007802
• UDI-Public: 00821925007802
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REXM3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2022
• 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