MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-27 for RF DENERVATION, 15 CM SPINE PROBE 7210272 * manufactured by Smith & Nephew Inc., Endoscopy Division.
[608296]
During rf procedure, an error 06 occurred. The customer used a back up and worked ok. There was a 45-minute delay reported in the case.
Patient Sequence No: 1, Text Type: D, B5
[7822417]
Device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216828-2007-00008 |
| MDR Report Key | 839861 |
| Report Source | 05 |
| Date Received | 2007-02-27 |
| Date of Report | 2007-02-23 |
| Date of Event | 2007-01-24 |
| Date Facility Aware | 2007-01-24 |
| Report Date | 2007-02-23 |
| Date Mfgr Received | 2007-01-24 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2007-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DONNA LANTEIGNE |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9787491576 |
| Manufacturer G1 | SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION |
| Manufacturer Street | 160 DASCOMB ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RF DENERVATION, 15 CM SPINE PROBE |
| Generic Name | PROBE, SPINE |
| Product Code | MUK |
| Date Received | 2007-02-27 |
| Model Number | 7210272 |
| Catalog Number | * |
| Lot Number | 376180 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 827147 |
| Manufacturer | SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
| Manufacturer Address | * ANDOVER MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-27 |