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

Model Number 242018

Device Problems Crack (1135); Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: outer tube damaged - bent/dented.Distal tip damaged- shaver damage to distal tip.High voltage flashover from electrode.Holes in distal tip fiber.Image error, on camera -image cloudy/blurred.Minor scratches on the unit.The defective parts were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.

Event Description

It was reported by the customer that during a cadaver lab, it was observed that the hd epscp,4.0,30,167,mitek endoscope device had a cracked scope.During in-house engineering evaluation, it was determined that the device had an image error on the camera as the image was cloudy/blurred.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: HD EPSCP,4.0,30,167,MITEK
• Type of Device: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13759986
• MDR Text Key: 291245542
• Report Number: 1221934-2022-00846
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705029150
• UDI-Public: 10886705029150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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: 242018
• Device Catalogue Number: 242018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1