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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL OVB1 CAMERA CONTROL UNIT EDNOSCOPIC VIDEO IMAGE PROCESSOR

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MEDOS INTERNATIONAL SàRL OVB1 CAMERA CONTROL UNIT EDNOSCOPIC VIDEO IMAGE PROCESSOR Back to Search Results
Catalog Number 242300
Device Problems Image Display Error/Artifact (1304); Computer Operating System Problem (2898)
Patient Problems Tissue Damage (2104); Not Applicable (3189)
Event Date 01/01/2018
Event Type  Injury  
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 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.
 
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Brand NameOVB1 CAMERA CONTROL UNIT
Type of DeviceEDNOSCOPIC VIDEO IMAGE PROCESSOR
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL S RL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key8083964
MDR Text Key127543256
Report Number1221934-2018-55346
Device Sequence Number1
Product Code FWF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number242300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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