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

Model Number M3-30A

Device Problems Corroded (1131); Fluid/Blood Leak (1250); 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 and with a leak; this is attributed to user mishandling.Corrosion was also noted at the tip.Other incidental observations were spots on the lens.

Event Description

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

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h4, and h10.Device history records (dhrs) for this product have been reviewed.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 damages observed on the device were most likely due to user mishandling.Corrosion is often incurred as a result of chemical stress and inappropriate storage environment.Section 6.0 (maintenance) and 7.0 (storage) of the device instructions for use (ifu) provide instructions regarding agents/solution and methods for appropriate cleaning, sterilization and storage of the device.Ifu alerts ¿use of any procedures not expressly recommended by gyrus acmi may adversely affect or damage gyrus acmi devices.¿ (section 6.0, page 12).The device ifu also provides warnings and cautions indicating that equipment may be damaged by misuse.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." (warnings and cautions, page 4).

• 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: 10617314
• MDR Text Key: 209588399
• Report Number: 1519132-2020-00082
• 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: 10/01/2020
• 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