MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ARTHSCO,4/140_30_QIK/STRKR HUB; RIGID ENDOSCOPE

Model Number 242043

Device Problem Crack (1135)

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

Event Date 10/20/2020

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.Udi: (b)(4).Investigation summary:the device was received and evaluated at the service center.The reported complaint that the scope was found to have a crack was confirmed.The following defects were found with the device upon evaluation : tube bent and dented.Distal tip damaged.Objective damaged.Objective window damaged.Eyepiece damaged.Image cloudy / foggy.The device was diagnosed and repaired using spare parts and was tested and found to be working according to specifications.The damage to the various components are most likely a result of user mishandling of the device.The damaged components are responsible for the poor image produced by the device.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 08/23/2017 and passed all functional testing before being returned to the customer.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 an unknown procedure on (b)(6) 2020, it was observed that the endoscope device was found to have a crack.During in-house engineering evaluation, it was determined that the image from the device was cloudy/foggy.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: ARTHSCO,4/140_30_QIK/STRKR HUB
• 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 CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 11012973
• MDR Text Key: 222072899
• Report Number: 1221934-2020-03870
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705026234
• UDI-Public: 10886705026234
• Combination Product (y/n): N
• PMA/PMN Number: K971996
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242043
• Device Catalogue Number: 242043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 12/15/2020
• 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