MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG; ADULT RESECTOSCOPE

Model Number M3-0A

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the user facility report was confirmed and testing found cracked lenses in the optical system, which was attributed to mishandling.Additionally, dents on the distal tip were observed.The device history review (dhr) of the m3-0a serial/lot number (b)(4) was shipped, manufactured june 2009, did not find any defects, non-conforming issue or any corrective action issues during the assembly build of the device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.  a capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting. .

Event Description

The customer reported that the device was blurry.There was no report of patient involvement, and no report of patient or user injury.No additional information was provided.

• Brand Name: M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 10538526
• MDR Text Key: 207218757
• Report Number: 1519132-2020-00071
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M3-0A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2009
• 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