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

Model Number 242018

Device Problem Crack (1135)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the scope lens was cracked.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: outer tube damaged, needle, outer tube bent, distal tip damaged, illumination, distal tip fiber damaged, optical system, optical components - broken lenses in optical system, less than 50% of lenses defective, minor scratches on the unit.The 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 sales rep that during a shoulder repair procedure on (b)(6) 2021, it was observed that the lens on the hd epscp,4.0,30,167,mitek endoscope device were cracked; and that the shaver went bad on a shoulder.During in-house engineering evaluation, it was determined that the device had broken lens in the optical system.There were no adverse patient consequences 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 (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: 12657042
• MDR Text Key: 277153307
• Report Number: 1221934-2021-03045
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• 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: 09/10/2021
• Date Manufacturer Received: 10/18/2021
• 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