MAUDE Adverse Event Report: GYRUS ACMI, INC. M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; HYSTEROSCOPE (AND ACCESSORIES)

Model Number REXM3-30A

Device Problem Sharp Edges (4013)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following that the object window had dents and sharp edges.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus the m3-gold autoclavable foroblique telescope 30 deg, distal end burning causing sharp edges.The issue occurred during the reprocessing.The procedure was diagnostic.There are no reports of patient or user harm associated with this event.There is a related record under: (b)(6); md 01/17/2024 (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional information was requested from customer: no further event information could be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 months since the subject device was manufactured.The device instructions for use document was reviewed.Review showed the following relevant instructions: "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." "keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active." during device investigation, the rigid distal tip was found to have sharp edges.Based on device appearance, it is likely that the damage resulted from improper handling.However, the root cause of the issue could not be conclusively determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide corrected information for model number and udi (d4).

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18528157
• MDR Text Key: 333475547
• Report Number: 3011050570-2024-00019
• Device Sequence Number: 1
• Product Code: HIH
• 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,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• 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: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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