Model Number HEMOPRO2 EXTENSION CABLE |
Device Problem
Material Frayed (1262)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Trackwise id # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
|
|
Event Description
|
The hospital reported that post use of an endoscopic vein harvesting procedure using hemopro2 extension cable, the end of the power cable was pulled improperly and the end broke and was pulled off.This took place at the end of a case during the room cleaning process.No patient involvement.
|
|
Manufacturer Narrative
|
Internal complaint number: (b)(4).This is a reusable oem device; therefore, a lot history/serial number review was not applicable.A lot/serial number was not provided and the specific product lot/serial number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.The device was returned to the factory for evaluation on 03/01/2021.An investigation was conducted on 03/11/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.One end of the connectors on the cable was found to be pulled and the inner components were exposed.The other connector end was observed to be intact, no visual defects were observed.Based on the returned condition of the device, the reported failure "material frayed" was confirmed.
|
|
Event Description
|
The hospital reported that post use of an endoscopic vein harvesting procedure using hemopro2 extension cable, the end of the power cable was pulled improperly and the end broke and was pulled off.This took place at the end of a case during the room cleaning process.No patient involvement.
|
|
Manufacturer Narrative
|
Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." (b)(4).
|
|
Event Description
|
The hospital reported that post use of an endoscopic vein harvesting procedure using hemopro2 extension cable, the end of the power cable was pulled improperly and the end broke and was pulled off.This took place at the end of a case during the room cleaning process.No patient involvement.
|
|
Search Alerts/Recalls
|