MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG; ADULT RESECTOSCOPE

Model Number M3-70A

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation the reported issue was confirmed.The no image issue was due to fractured lens.The outer tube was found bent, and it has a dent.The objective window was visually inspected, and minor scratches were found with minor debris underneath the cover glass on the distal tip.Minor scratches were also observed on the eye cup.No other issues or injuries have been reported.If any additional information is obtained a follow up report will be filed.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

A user facility reported a scope with no image during a procedure.No patient harm was reported.No additional information was obtained.

Manufacturer Narrative

The unique device identifier (udi) number and correct serial number has been provided.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.No other issues were reported.If additional information is obtained a supplemental report will be filed.

• Brand Name: M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10528604
• MDR Text Key: 206773971
• Report Number: 1519132-2020-00069
• 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: 09/16/2020

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: 03/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1