MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL OVB1 CAMERA CONTROL UNIT; EDNOSCOPIC VIDEO IMAGE PROCESSOR

Model Number	242300
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event reportedly occurred on an unknown date in 2019.It noted that on an unknown date the device was received at the service center.Initial reporter is a mitek employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.
Event or Problem Description
Device report from mitek (b)(6) reports an event as follows: it was reported by the affiliate via cst that during a hysteroscopy when switching on the ovb1 camera control unit and the tck1 hd camera head it showed an error 0128 and the camera went off.It is unknown if the surgery was delayed due to the reported event or if it was completed.No additional information was provided.This report is for a tck1 hd camera head.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary : the device was received and evaluated at the service center.The reported complaint that the device showed error code and went off was unable to be confirmed.No faults were found with the device upon evaluation.The device was tested and found to be working according to specifications.Since the reported condition is not confirmed,the root cause for the reported failure cannot be determined.No non-conformances were identified for this part (242300) - lot number(1300280002) combination as per qlik query executed (b)(6) 2019.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).

• Brand Name: OVB1 CAMERA CONTROL UNIT
• Common Device Name: EDNOSCOPIC VIDEO IMAGE PROCESSOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9203470
• Report Number: 1221934-2019-59064
• Device Sequence Number: 11527548
• Product Code: FWF
• UDI-Device Identifier: 10886705026180
• UDI-Public: (01)10886705026180
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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: 242300
• Device Catalogue Number: 242300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1