MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG; HYSTEROSCOPE AND ACCESSORIES

Model Number M3-70A

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation the reported issue was confirmed.Excessive debris was found underneath the cover glass on the distal tip.There was minor debris underneath the cover glass on the eye cup.No image was present due to fractured lens.No other issues or injuries have been reported.If any additional information is obtained a follow up report will be filed.

Event Description

A user facility reported cracked lens on a scope.The issue was found during preparation of a procedure.No patient involvement or harm was reported.No additional information has been obtained.

Manufacturer Narrative

This event was observed on july 2, 2020 when the tech opened the scope and noticed the crack in the lens.The scope was one that had previously been repaired.There was no delay in the intended procedure and the intended procedure was completed.There was no patient harm or injuries.The same device was not used to complete the procedure.No other devices were replaced during the procedure.The user facility also informed olympus that there was no visual deformation such as kinks or buckles on the bending section of the scope.No anomalies were observed during inspection.A leak test was not performed as this is a rigid scope.The device is reprocessed per an autoclaved temp exposure time, 4 minutes.The scope is stored with the other instruments in the set.No metal was protruding, and the bending section was not broken.A device history record (dhr) did not find any defects or nonconformities.All records indicate that the device was manufactured in accordance with all applicable procedures.The probable cause for the reported event is excessive force during handling.

• Brand Name: M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG
• Type of Device: HYSTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10363682
• MDR Text Key: 217463436
• Report Number: 1519132-2020-00043
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

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: M3-70A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1