MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OVB1 CAMERA CONTROL UNIT; ENDOSCOPIC VIDEO IMAGE PROCESSOR

Catalog Number	242300
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/10/2018
Type of Reportable Event	Serious Injury
Additional 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.(b)(6).Investigation summary: the device was sent to the service center for repair.The work order indicates that a defective isolation board was found.It was replaced and the device testing passed.The defective board is the root cause of this failure.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint can be confirmed.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.(b)(4).
Event or Problem Description
It was reported by the affiliate via email that their ovb1 camera had stopped giving output on its screen during the surgery.Additional information provided by the affiliate on 01/15/19 reporting that there was a surgical delay of 20 to 30 minutes and the surgery had to be called off due to the malfunction.Additional information provided by the affiliate on 01/16/19 stating that the patient was already under anesthesia when the procedure was cancelled.

• Brand Name: OVB1 CAMERA CONTROL UNIT
• Common Device Name: ENDOSCOPIC VIDEO IMAGE PROCESSOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8332975
• Report Number: 1221934-2019-56383
• Device Sequence Number: 1304363
• Product Code: FWF
• UDI-Device Identifier: 10886705026180
• UDI-Public: 10886705026180
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/12/2019
• Patient Sequence Number: 1