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 12/29/2020

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.Additional narrative: (b)(4).Investigation summary: the complaint device was sent to the supplier and evaluated.It was reported that scope was cracked.Per service report, this complaint can be confirmed.The following defects were found during evaluation: outer tube damaged, distal tip.Distal tip damaged.Distal tip has deposits.Optical system, optical components.Broken lenses in optical system.Additionally, minor scratches were identified with the device upon decontamination.The defective parts were replaced, and the device was tested and found to be working according to specifications.The physical damages to the device including damage to the distal tip and broken lenses in optical system are most likely a result of user mishandling of the device or a possible fall.The deposits on distal tip were caused by improper cleaning of the endoscope by the customer after the usage.There are no indications from this complaint investigation that the issue/failure is manufacturing-related, therefore a manufacturing record evaluation is not required.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 knee procedure on (b)(6) 2020, it was observed that the endoscope device was cracked.During in-house engineering evaluation, it was determined that the device had broken lenses in the optical system.Another like device was used to complete the procedure without delay.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: 11530128
• MDR Text Key: 243745541
• Report Number: 1221934-2021-00908
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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: 02/09/2021
• Date Manufacturer Received: 03/18/2021
• 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: Initial
• Patient Sequence Number: 1