STARFISH 2 HEART POSITIONER
Received Dec 14, 2004
Report 2135394-2004-00007 · MDR key 792695
Device
Generic name
Heart Positioner
Manufacturer
Medtronic Perfusion SystemsModel number
29800Catalog number
29800
Lot number
UNK
Product problems
- Detachment Of Device Component
Patient
UNKNOWN
- Surgery, prolonged
- No Consequences Or Impact To Patient
- Foreign body, removal of
Narrative
Description of Event or Problem
INFORMATION RECEIVED INDICATES THAT DURING THE CASE, A COMPONENT DETACHED FROM THE PRODUCT AND HAD TO BE RETRIEVED FROM THE PT'S CHEST CAVITY. THE CASE WAS COMPLETED WITH NO CONSEQUENCE REPORTED FOR THE PT.
Additional Manufacturer Narrative
EVALUATION METHOD CODE: DEVICE NOT RETURNED TO MANUFACTURING FOR ANALYSIS AND PRODUCT SPECIFIC INFORMATION (MANUFACTURING LOT NUMBER) WAS NOT PROVIDED. ANALYSIS: THE PRODUCT HAS NOT BEEN RETURNED TO MANUFACTURING FOR ANALYSIS. WITHOUT PRODUCT RETURN REVIEW IS LIMITED AND NO RESULTS CAN BE PROVIDED. PRODUCT SPECIFIC INFO (MANUFACTURING LOT NUMBER) HAS NOT BEEN PROVIDED BY THE USER. REVIEW OF EVENT INFO SHOWS THE COMPONENT DETACHED FROM THE PRODUCT WHEN THE DEVICE WAS REMOVED FROM THE RETRACTOR DURING THE CASE. THE COMPONENT WAS INTRA-OPERATIVELY RETRIEVED AND THE CASE COMPLETED WITH NO REPORT OF PATIENT COMPLICATION. THE DATE OF THE REPORTED EVENT IS UNKNOWN. CONCLUSION: NO PATIENT EVENT AND NO PRODUCT RETURN; NO CONCLUSION CAN BE DRAWN FOR THE REPORTED PRODUCT PROBLEM.