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

Model Number 242018

Device Problems Display or Visual Feedback Problem (1184); Loose or Intermittent Connection (1371); Dent in Material (2526); Material Twisted/Bent (2981); Scratched Material (3020)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during return inspection, it was determined that a hd arthroscope/sinuscope 4.0mm x 30 deg x 167mm (mitek lock) device had cloudy lens.There was no procedure nor patient involvement reported.No additional information was provided.No patient or surgical involvement.

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.Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device had cloudy lens.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: outer tube damaged, bent/dented; distal tip damaged; field stop defect, field stop loose; 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.

• 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 (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12086422
• MDR Text Key: 262508126
• Report Number: 1221934-2021-02020
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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: 08/03/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2021
• 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