MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TCK1 HD CAMERA HEAD; ENDOSCOPIC VIDEO CAMERA

Model Number	242400
Medical Device Problem Code	Intermittent Capture (1080)
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
Device was used for treatment, not diagnosis.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 by the affiliate in (b)(6) that during an unknown procedure, it was observed that the display of the tck1 hd camera head was getting lost every two seconds when the head was connected to the control unit.No patient consequence and no surgical delay was reported.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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: correction: d10: the date device returned to manufacturer was reported as 2/7/2020 on the previous report.It has been updated as 1/13/2020 to reflect the correct information.
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: 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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: e1, g3: initial reporter name, facility name and address have been updated to reflect the correct information.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the display was lost in every two second when the head was connected to the control unit.It was reported that the event occurred prior to the knee arthroscopy (anterior cruciate ligament (acl) surgical procedure.It was reported that there was a delay of 30 minutes.It was reported that there were no patient consequences or impact to the user or patient.It was reported that the case was not completed.It was reported that an alternative product was readily available.It was reported there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: additional information: investigation summary = > the complaint device was received at the service center and evaluated.During evaluation, poor display issue was found, therefore this complaint can be confirmed.The device was found to be non-repairable and hence it was not restored to the specification.It was replaced/exchanged to the customer.With the available information, we cannot determine the root cause of the reported problem.A device history review 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 device history review was performed for the finished device serial number (b)(6), and no non-conformances were identified.

• Brand Name: TCK1 HD CAMERA HEAD
• Common Device Name: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9546624
• Report Number: 1221934-2020-00023
• Device Sequence Number: 11348134
• Product Code: FWF
• UDI-Device Identifier: 10886705026258
• UDI-Public: 10886705026258
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/20/2019

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: 242400
• Device Catalogue Number: 242400
• Device Lot Number: OM01945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/07/2020; 02/11/2020; 03/11/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/07/2020; 02/07/2020; 02/11/2020; 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1