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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SàRL OVB1 CAMERA CONTROL UNIT; ENDOSCOPIC VIDEO IMAGE PROCESSOR Back to Search Results
Catalog Number 242300
Device Problems Intermittent Loss of Power (4016); Intermittent Energy Output (4025)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2018
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  no further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
It was reported by the sales rep that before an unspecified surgical procedure, it was observed that the power button on the ovb1 camera control unit device was working intermittently.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device was available for use.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand Name
OVB1 CAMERA CONTROL UNIT
Type of Device
ENDOSCOPIC VIDEO IMAGE PROCESSOR
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ   CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key9033710
MDR Text Key188679307
Report Number1221934-2019-58294
Device Sequence Number1
Product Code FWF
UDI-Device Identifier10886705026180
UDI-Public10886705026180
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/20/2018
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
Device Operator Health Professional
Device Catalogue Number242300
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/20/2018
Initial Date FDA Received09/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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