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

Model Number M3-30A

Device Problem Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

The supply chain surgical coordinator at the user facility further reported the brightness of the examination light was set to the minimum necessary to perform the procedure safely.The examination lamp is not old.The objective lens was not dirty.The video system center and/or light source cable was connected properly.No foreign objects such as detergent remnants, hard water residue, finger grease, dust and lint are on the electrical contacts.The cord was not coiled, bunched or kinked.The scope connector, video scope cable and video system center was connected properly.There was no damage or abnormalities noted when the scope was inspected.The scope is being leak tested prior to manual cleaning.The scope is being stored in a tray.The date the event occurred on was (b)(6) 2020.This issue occurred during the procedure.The type of procedure being performed was a cysto with stent insertion, which was therapeutic.No other devices were involved in the event.There was no delay in the procedure.The procedure was completed.However, the same device was not used to complete the procedure.It is unknown what other devices were used to replace the device during the procedure.The device failed in the beginning of the procedure.The referenced scope was returned to the service center for repair evaluation.The evaluation found a dent on the rigid outer tube shaft.Additionally, there was a chipped objective coverglass and broken light fibers at the distal end.There was minor debris under the eyepiece coverglass and the image was cloudy due to a fractured lens.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.The m3-30a serial (b)(4) was shipped as a repair / exchange (rex) scope.The rigid scope was last serviced via repair on november 16, 2016 for a broken/damaged eyepiece.The investigation was completed and the oem determined that there was no manufacturing, material or processing related cause for this failure mode.Based on the evaluation results, the root cause has been determined to be excessive force / stress from impact or handling.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 service center became aware during a standard inspection, that the autoclavable 30 degree rigid telescope had a blurry image.There was no patient injury reported.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• 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: 10486193
• MDR Text Key: 209168188
• Report Number: 1519132-2020-00062
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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: 04/23/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• 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
• Patient Age: 68 YR