MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CAMERA HEAD AC - C-MOUNT; ENDOSCOPIC VIDEO CAMERA

Model Number 242401

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

As reported by the healthcare employee via phone, their rep was there today and noticed a broken wire on the camera head.No case involved.

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: correction: h6: result codes: further investigation determined that the result code and investigation summary were both inaccurate on the previous report.Therefore, both fields have been updated accordingly to reflect the correct information.Investigation summary
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> the complaint device was received at the service center and evaluated.It was reported by the healthcare employee via phone, their rep was there today and noticed a broken wire on the camera head.Per service manual operational and diagnostic, the reported failure was not confirmed.  during evaluation, the reported issue cannot be duplicated.In addition, the display was not presented image.The repair was declined, and it was not restored to the specifications.It is being placed into long term hold.With the given information, we cannot determine the root cause of the reported problem.  a manufacturing record evaluation was performed for the finished device [1801ce0363] number, and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

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: d4: the serial number was reported as unknown on the initial report and has been updated as (b)(6).Therefore, udi: (b)(4).H6: method codes: a manufacturing record evaluation was performed for the finished device [(b)(6)] number, and no non-conformances were identified.

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.Investigation summary the complaint device was received at the service center and evaluated.It was reported by the healthcare employee via phone, their rep was there today and noticed a broken wire on the camera head.Per service manual operational and diagnostic, the reported failure was confirmed.  during evaluation, the display was found defective due to the image was not activated.In addition, the wires were exposed.The repair was declined and it was not restored to the specifications.It is being placed into long term hold.With the given information, we cannot determine the root cause of the reported problem.  a manufacturing record evaluation was performed for the finished device [1801ce0363] number, and no non-conformances were identified.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

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: 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: CAMERA HEAD AC - C-MOUNT
• Type of Device: ENDOSCOPIC VIDEO CAMERA
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10235565
• MDR Text Key: 202233351
• Report Number: 1221934-2020-01749
• Device Sequence Number: 1
• Product Code: FWF
• UDI-Device Identifier: 10886705028733
• UDI-Public: 10886705028733
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242401
• Device Catalogue Number: 242401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 08/27/2020
• Patient Sequence Number: 1