MAUDE Adverse Event Report: GYRUS ACMI, INC. REPAIR SCOPE AUTOCLAVABLE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number REXM3-12A

Device Problems Mechanical Problem (1384); Melted (1385)

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

Event Type  malfunction  

Event Description

Company representative sent the device for repair reported with an issue of " view is obscured¿.No harm was reported.No patient harm, no user injury reported.Device evaluation found burnt distal end.This report is being submitted due to the finding of burnt distal end identified during device return evaluation.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation has confirmed the reported issue of "view is obscured¿.Evaluation and inspection found blurry image, chipped lens, debris and humidity in the optical system.In addition, dirt and stain in the objective unit, and burnt distal end were observed.Device history record was reviewed and showed the product met all specifications upon release.Based on the investigation, the damage which occurred to the scope was most likely due to user mishandling.In addition, the observed defects contributed to the image issue experienced by the user.The device instruction for use (ifu_99-1080_bg) provides warnings and cautions to alert that the device may be damaged by improper handling.It 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;" "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.

• Brand Name: REPAIR SCOPE AUTOCLAVABLE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16245291
• MDR Text Key: 309188236
• Report Number: 1519132-2023-00004
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2023

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 Number: REXM3-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• 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