MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL HD EPSCP,4.0,70,175,CW_STORZ; RIGID ENDOSCOPE

Model Number	242009
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.(b)(6).Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had scratch and stain on it was confirmed.It was found that the device produced a bad image.Also the distal tip and optics were damaged and the shaft was bent.The damaged distal tip, optics and shaft were replaced and the device was cleaned, tested and found to be fully functional.The physical damage to the device is a result of user mishandling of the device, probably during storage or transportation.The damaged components would have caused the device to not function as intended by the customer.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformance's 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.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that during an unknown procedure the hd epscp, 4.0, 70 , 175, cw_storz has stains and scratches.No patient consequence and no surgical delay was reported.No additional information was provided.

• Brand Name: HD EPSCP,4.0,70,175,CW_STORZ
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9780863
• Report Number: 1221934-2020-00726
• Device Sequence Number: 14116016
• Product Code: HRX
• UDI-Device Identifier: 10886705028788
• UDI-Public: 10886705028788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080560
• 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): 02/17/2020

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: 242009
• Device Catalogue Number: 242009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/03/2020
• Patient Sequence Number: 1