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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CAMERA HEAD AC - C-MOUNT; ENDOSCOPIC VIDEO CAMERA
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MEDOS INTERNATIONAL SàRL CAMERA HEAD AC - C-MOUNT; ENDOSCOPIC VIDEO CAMERA Back to Search Results
Catalog Number 242401
Device Problems Break (1069); Intermittent Continuity (1121)
Patient Problem Not Applicable (3189)
Event Date 11/21/2019
Event Type  malfunction  
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.Udi: (b)(4).
 
Event Description
As reported by the sales rep via phone, the cable on the camera head acc-mount appears to be broken internally.The image generated on the screen flashes in and out and produces color jumping all around the screen.The case was delayed by five minutes to replace unit with a like device with no patient harm.
 
Manufacturer Narrative
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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: h6: method codes: device history lot: the service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6) 2019 and passed all functional testing before being returned to the customer.Investigation summary: the complaint device was received at the service center and evaluated.The sales rep reported an issue of the cable on the device appeared to be broken internally and the image generated on the screen flashed in and out and produced color jumping all around the screen.Per service manual operational and diagnostic, the device was found to be working intermittently, therefore this complaint can be confirmed.The repair was declined and the device was not restored to the specifications.It is being placed into long term hold.With the available information, we cannot determine the root cause of the reported problem.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on (b)(6) 2019 and passed all functional testing before being returned to the customer.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.Device history lot: the service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 10/03/2019 and passed all functional testing before being returned to the customer.
 
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Brand Name
CAMERA HEAD AC - C-MOUNT
Type of Device
ENDOSCOPIC VIDEO CAMERA
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9418604
MDR Text Key197342980
Report Number1221934-2019-59860
Device Sequence Number1
Product Code FWF
UDI-Device Identifier10886705028733
UDI-Public10886705028733
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number242401
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Date Manufacturer Received01/09/2020
Patient Sequence Number1
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