MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ARTHSCP,4/175_30_JL/STORZ HUB; RIGID ENDOSCOPE

Model Number	242012
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the complaint device was received at the supplier facility and evaluated.It was reported that the optics was not working.Per evaluation findings, this complaint can be confirmed.It was found during evaluation that the distal tip, objective and window were damaged and bent.Further, the image was dark with shadow.The repair was declined; therefore, the device was not restored to the specifications.It was discarded as requested.User mishandling, lack of maintenance, a fall from the customer, excessive force applied and/or hit with another instrument are the most probable root causes of the damages observed.The damaged and bent components would have caused the poor image quality.A manufacturing record evaluation was performed for the finished device serial number (b)(4), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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 from (b)(6) that the endoscope device was not working.During in-house engineering evaluation, it was determined that the image on the device was dark with shadow.No additional information was provided.

• Brand Name: ARTHSCP,4/175_30_JL/STORZ 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: 10516300
• Report Number: 1221934-2020-02519
• Device Sequence Number: 3868971
• Product Code: HRX
• UDI-Device Identifier: 10886705026210
• UDI-Public: 10886705026210
• Combination Product (Y/N): N
• PMA/510(K) Number: K971996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 242012
• Device Catalogue Number: 242012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1