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

Model Number	242012
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via email that when 2 of the arthscp,4/17530jl/storz hub arrived had stains that could not be removed.No patient consequence and no surgical delay was reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device was received at the service center and evaluated.It was reported that the optics had stains that could not be cleaned.This complaint can be confirmed.It was identified that the tube was bent and the optics was damaged.The repair was declined and the device was discarded.User mishandling and lack of maintenance can be the most probable root causes of the failures.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ARTHSCP,4/175_30_JL/STORZ HUB
• Common Device Name: RIGID ENDOSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9836805
• Report Number: 1221934-2020-00862
• Device Sequence Number: 13840739
• Product Code: HRX
• UDI-Device Identifier: 10886705026210
• UDI-Public: 10886705026210
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup,Followup
• Report Date (Section B): 03/02/2020

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: 10/19/2020
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 11/03/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 11/02/2020; 11/04/2020
• Patient Sequence Number: 1