MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,70,167,MITEK; RIGID ENDOSCOPE

Model Number	242021
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and evaluated at the service center.The reported complaint that the device had cloudy lens was confirmed.The following failures and actions were identified and taken with the device during evaluation : dent in outer tube.Outer tube bent.Distal tip damaged.Broken illumination fibers, transmission.Endoscope body damaged / scratched exchange of outer tube glass particles in optical system.The device was repaired, tested and found to be working according to specifications.The above damages to the device are most probably caused due to user mishandling of the device, possibly a fall.However, given the information provided we cannot discern a definitive root cause for the same.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.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.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4), and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on a unknown date the complaint for a scope was reported to have a cloudy lens.No surgical procedure was performed.This report is for one (1) hd epscp,4.0,30,167.This is report 1 of 1 for (b)(4).

• Brand Name: HD EPSCP,4.0,70,167,MITEK
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9239289
• Report Number: 1221934-2019-59208
• Device Sequence Number: 1646030
• Product Code: HRX
• UDI-Device Identifier: 10886705028986
• UDI-Public: (01)10886705028986
• Combination Product (Y/N): N
• PMA/510(K) Number: K080560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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: No Information
• Device Model Number: 242021
• Device Catalogue Number: 242021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 10/25/2019
• Patient Sequence Number: 1