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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Medos International Sàrl CAMERA HEAD AC - C-MOUNT; Camera, Television, Endoscopic, Without Audio

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Medos International Sàrl CAMERA HEAD AC - C-MOUNT; Camera, Television, Endoscopic, Without Audio Back to Search Results
Catalog Number 242401
Medical Device Problem Codes Electrical /Electronic Property Problem (1198); Unintended Movement (3026)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/09/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during an unspecified arthroscopic procedure the camera head ac - c-mount device starts to short out when try to plug in/ loose wire.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.
 
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
 
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Brand Name
CAMERA HEAD AC - C-MOUNT
Common Device Name
Camera, Television, Endoscopic, Without Audio
Manufacturer (Section D)
Medos International Sàrl
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
Medos International SÃ rl
chemin-blanc 38
le locle 02400
SZ   02400
Manufacturer Contact
elba bello
325 paramount drive
raynham, MA 02767
+1(908)386-3534
MDR Report Key50776719
Report Number1221934-2026-04138
Device Sequence Number10664435
Product Code FWF
UDI-Device Identifier10886705028733
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
Exempt
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source Company Representative
Type of Report Initial
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
Operator of Device Health Professional
Device Catalogue Number242401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/09/2026
Initial Report FDA Received Date09/15/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)
No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
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