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

Catalog Number	242300
Medical Device Problem Codes	Image Display Error/Artifact (1304); Computer Operating System Problem (2898)
Health Effect - Clinical Codes	Tissue Damage (2104); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: the device was received and repaired at the service center.The complaint was confirmed.The following information was derived from the service report: checked and found isolation board defective.Replaced the same & tested ok.When the isolation board is defective the device will not function as intended and error code 129 will be triggered, therefore is a root cause for the reported failure.At this point, 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that an error 129 showed up on the console.As a result, there was a delay of two hours in the surgical procedure.It was reported that during the two hour surgical delay, the affiliate indicated that the surgeon had to switch to an open surgery to complete the procedure.It was reported that there were no alternatives readily available.There was patient involvement reported.It was reported that there were no patient impact.However, it was not reported if there were any medical intervention or prolonged hospitalization.The status of the patient post-surgery was unknown.The exact date of the event was unknown but was noted to have occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 8083964
• Report Number: 1221934-2018-55346
• Device Sequence Number: 19266075
• Product Code: FWF
• UDI-Device Identifier: 10886705026180
• UDI-Public: 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
• Report Date (Section B): 11/19/2018

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: 03/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1