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)
Date of Event	12/20/2019
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).Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that during an unknown procedure the arthscp, 4/175_30_jl/storz hub had vision problems.No patient consequence and no surgical delay was reported.No additional information was provided.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.It was reported that the device had vision issue.Per evaluation, this complaint can be confirmed.The device was found to be non-repairable and hence it was not restored to the specifications.It was replaced/exchanged to the customer.With the available information, we cannot determine the root cause of the reported problem.A manufacturing record evaluation was performed for the finished device serial number (b)(6), 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.Device history lot: a manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformances were identified.
Additional Manufacturer Narrative
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.H10 additional narrative: correction: b3: the date of event was reported as (b)(6) 2019 on the initial report and has been updated to (b)(6) 2019 to reflect the correct information.E1, g3: the initial report name, facility name and address have been updated accordingly to reflect the correct information.Therefore, report source has been updated.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the event - the display was lost in every two seconds when the head was connected to the control unit, occurred prior to knee arthroscopy acl (anterior cruciate ligament) surgical procedure.It was reported there was a delay of 30 minutes to the surgical procedure.It was reported that the case was not completed.It was reported an alternative product readily available.It was reported that there were no patient consequences or impact to the user or patient.It was reported that there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions).
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: correction: b3: the date of event was reported as 12/24/2019 on the initial report and has been updated as 12/20/2019.Additional information: 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: 9555387
• Report Number: 1221934-2020-00052
• Device Sequence Number: 17009799
• Product Code: HRX
• UDI-Device Identifier: 10886705026210
• UDI-Public: 10886705026210
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K971996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/24/2019

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: Health Professional
• Device Model Number: 242012
• Device Catalogue Number: 242012
• Device Lot Number: 25846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 01/22/2020; 02/18/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/07/2020; 02/18/2020; 02/19/2020
• Patient Sequence Number: 1