MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG

Model Number M3-30A

Device Problems Break (1069); No Display/Image (1183)

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.The device was returned to the service center for evaluation.The outer tube of the device was found bent.The device¿s e/p window unit and funnel cup were inspected minor dents on the on the eyecup were noted.In addition, minor debris was noted underneath the cover glass on the eyecup.The optical fiber system was inspected and found no image due to a fractured lens.The device was repaired and returned to the customer.

Event Description

The service center was informed that during reprocessing the rod and lens of the device were noted to be broken and no image was observed.There was no report of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report is being submitted to correct the serial number from 787585c to 787585.Please see the updates in sections: d4, g4, g7, h2 and h10.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the contents of this complaint.The dhr review of the m3-30a serial/lot number (b)(6) was shipped as an rex scope, manufactured november 2019, did not find any defects, nonconforming 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.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: M3-GOLD AUTOCLAVABLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10382585
• MDR Text Key: 217463328
• Report Number: 1519132-2020-00046
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 0082195007802
• UDI-Public: (01)0082195007802
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2020

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: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 10/29/2020; 11/05/2020
• Supplement Dates FDA Received: 09/23/2020; 11/11/2020; 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1