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

Model Number	242043
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: udi: (b)(4).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the scope was bent, was confirmed.The following defects were found with the device upon evaluation : fiber recessed.Tube bent and dented.Distal tip, objective and window damaged.Optics damaged.Image cloudy / foggy.The objective, objective window and the rod lens were replaced, internal scope was cleaned, eyepiece was laser weld as per the specifications and the device was tested and found to be working according to specifications.The identified failures shows clear signs of user mishandling by the customer, which would in turn have caused the device to display a poor image.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 09/10/2018 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 or Problem Description
It was reported by the sales rep that during an unknown surgery on (b)(6) 2021, it was observed that the endoscope device was bent.During in-house engineering evaluation, it was determined that the image was cloudy and foggy on the device.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
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11589489
• Report Number: 1221934-2021-01017
• Device Sequence Number: 4845937
• Product Code: HRX
• UDI-Device Identifier: 10886705026234
• UDI-Public: 10886705026234
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K971996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: 242043
• Device Catalogue Number: 242043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1