MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,30,167,MITEK; RIGID ENDOSCOPE

Model Number 242018

Device Problem Poor Quality Image (1408)

Patient Problem Not Applicable (3189)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

As reported by the healthcare professional via email, during a knee surgery the hd ep scope was found to be blurry.There was a delay in the case due to having to get another scope.No patient harm.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: correction: d10: the date device returned to manufacturer has been updated to reflect the correct information.Investigation summary
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> the complaint device was received at the supplier facility and evaluated.It was reported that the scope was blurry.Per evaluation findings, this complaint can be confirmed.During evaluation, it was observed that the outer tube and distal tip were damaged.There were broken lenses in the optical system.It was also found that less than 50% of the lenses were defective.The issues were resolved with spare parts, and the device was found to be fully functional after performing the repair activities.The damaged components and broken lenses are identified as the root causes of the reported problem.User mishandling, lack of maintenance, fall of the device from the customer by mistake, hit with another sharp instruments and/or excessive force applied are the most probable root causes of the damages observed.A manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: HD EPSCP,4.0,30,167,MITEK
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9637868
• MDR Text Key: 200806938
• Report Number: 1221934-2020-00335
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705029150
• UDI-Public: 10886705029150
• Combination Product (y/n): N
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242018
• Device Catalogue Number: 242018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Date Manufacturer Received: 08/26/2020
• Patient Sequence Number: 1