MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-01-20 for GAMMAPLAN VERSION 5.12 NA manufactured by Elekta Instrument Ab.
[143799]
While using the treatment planning software, the physician used the plug shields feature, and then merged the plug patterns. He then created a new plan and chose the "copy existing plan" feature. Upon copying, the leksell gammaplan software gave an error stating that plug pattern "helmet 18a not found. " the shot menu showed only the pattern "none" for each of the shots. The plug menu showed no plugs. However, the protocol printout gave times as if the plugs still existed without printing any plugs and the isodose curves behaved as if the plugs were still there. This was true for both the original plan and for the copy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612186-1999-00001 |
| MDR Report Key | 207034 |
| Report Source | 06 |
| Date Received | 1999-01-20 |
| Date of Report | 1998-12-22 |
| Date of Event | 1998-12-22 |
| Date Facility Aware | 1998-12-22 |
| Report Date | 1998-12-22 |
| Date Reported to Mfgr | 1998-12-22 |
| Date Mfgr Received | 1998-12-22 |
| Device Manufacturer Date | 1998-12-01 |
| Date Added to Maude | 1999-01-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAMMAPLAN |
| Generic Name | TREATMENT PLANNING SOFTWARE |
| Product Code | LMX |
| Date Received | 1999-01-20 |
| Model Number | VERSION 5.12 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 200955 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | BIRGER JARLSGATAN 53 STOCKHOLM SW S-103 93 |
| Baseline Brand Name | GAMMAPLAN |
| Baseline Generic Name | TREATMENT PLANNING SOFTWARE |
| Baseline Model No | VERSION 5.12 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-01-20 |