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

Model Number M3-30A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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.There is no additional information available for this event.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not known.The user¿s complaint was confirmed.Upon inspection, the device distal tip was observed to be bent.Cause for this damage could not be conclusively determined.Other incidental observations were image issues of shadow on edge from fiber breakage.

Event Description

As reported for this event, during reprocessing the distal tip of the device was damaged.There is no patient involvement.There is no harm or adverse impact to patient, or anyone else.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Device history records (dhrs) for this product have been reviewed.This unit was produced in (b)(6) 2017.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.There are no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.The instructions for use includes the following statements: the found failures were most likely due to user mishandling as the event was found during reprocessing.The device instructions for use (ifu) provides warnings and cautions indicating that the device may be damaged by misuse.Warnings on page 4 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.".

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10645814
• MDR Text Key: 210443757
• Report Number: 1519132-2020-00087
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

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: No Information
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1