DORO® SKULL CLAMP RADIOLUCENT
Report
- Report Number
- 3003923584-2022-00006
- Event Type
- Injury
- Date Received
- April 27, 2022
- Date of Event
- March 29, 2022
- Report Date
- April 1, 2022
- Manufacturer
- PRO MED INSTRUMENTS GMBH
- Product Code
- HBL
- UDI-DI
- 04250435502181
- PMA / PMN Number
- K032331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE CUSTOMER HAS NOT YET SENT THE PRODUCT IN FOR INVESTIGATION. WE WILL PERFORM A FOLLOW-UP AS SOON AS THE PRODUCT HAS ARRIVED AND THE FINDINGS HAVE BEEN COMPLETED.
AS THE DEVICE IS IN SPECIFICATION AND DID NOT SHOW ANY DEVIATION THAT COULD CAUSE THE REPORTED INCIDENT WE SUSPECT, THAT MAYBE THE PINNING TECHNIQUE HAS BEEN NOT OPTIMAL AS DESCRIBED IN THE INSTRUCTION MANUAL: "ADJUST THE SKULL CLAMP TO THE WIDTH OF THE PATIENT'S HEAD IN THE MANNER THAT THE TWO SKULL PINS IN THE ROCKER ARM ARE EQUIDISTANT FROM THE CENTERLINE OF THE HEAD AND THE SINGLE SKULL PIN AT THE EXTENSION ASSEMBLY IS IN LINE WITH THIS CENTERLINE." WE RECOMMEND USING OUR SKULL PINS IN COMBINATION WITH OUR SKULL CLAMPS. RISKS DUE TO NOT PERMITTED SYSTEM COMBINATIONS WITH THIRD PARTY COMPONENTS COULD NOT BE EXCLUDED, AS IN THIS CASE.
CUSTOMER INFORMED OUR SERVICE DEPARTMENT ON THE 1ST OF APRIL THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE WHERE A LACERATION OCCURED.
NO FURTHER DESCRIPTION FOR THIS FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1479389 | DORO® SKULL CLAMP RADIOLUCENT | DORO® SKULL CLAMP RADIOLUCENT | HBL | PRO MED INSTRUMENTS GMBH | 3034-00 | 04250435502181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |