MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-10-16 for ACCUSEED DS 1-2174 NA manufactured by Computerized Medical Systems, Inc..
[20160789]
A user was performing a procedure involving the implanting of radioactive seeds into the prostate for brachytherapy. After placing several of the seeds, the radiation oncologist and urologist concluded that the seeds had been misplaced. The seeds were retracted, and the patient was not harmed. Investigation revealed that the user had inadvertantly overturned the in/out adjustment knob, causing the encoder to lose its calibrated zero position.
Patient Sequence No: 1, Text Type: D, B5
[20550123]
Investigation of this issue was extensive and included both an onsite visit as well as return of the device to cms for further evaluation. The customer's initial report stated that the seeds were misplaced by 3cm. However, investigation revealed that the overextended knob accounted for only half the error. It is possible that miscalibration accounted for the other half, though the customer indicated that calibration had been verified and was accurate. It was a known possibility that the user could break the stepper by overturning the knob. An earlier version of the attached customer advisory had warned users about this possibility. What was not known was that this could result in the interplant brachytherapy treatment planning software, with which the accuseed ds was being used, to incorrectly report the exposed needle distance. This is not incorrect functioning for interplant; it is a result of the customer using a broken accuseed system. An additional complicating factor in this situation was that the user was referencing only the exposed needle distance in placing the seeds; this is not standard practice. While cms feels that this was clearly a case of user error, we chose to report it to fda and initiate a voluntary recall because this customer's report would seem to indicate that the potential for mistreatment if the user does make this error is greater than initially anticipated. The attached customer advisory is being sent to all accuseed ds customers. The advisory tells customers to perform a test to ensure that the system is functioning properly before each procedure. Cms is currently modifying the design to further mitigate the risk of a user overturning the knob, and a voluntary recall will be initiated to rework all accuseed ds systems accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1937649-2006-00006 |
| MDR Report Key | 808536 |
| Report Source | 05,06 |
| Date Received | 2006-10-16 |
| Date of Report | 2006-10-13 |
| Date of Event | 2006-08-11 |
| Date Mfgr Received | 2006-08-11 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-01-26 |
| 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 | 0 |
| Manufacturer Street | 1145 CORPORATE LAKE DR. |
| Manufacturer City | ST LOUIS MO 63132 |
| Manufacturer Country | US |
| Manufacturer Postal | 63132 |
| Manufacturer Phone | 3149930003 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUSEED DS |
| Generic Name | BRACHYTHERAPY STEPPER/STABILIZER |
| Product Code | IWJ |
| Date Received | 2006-10-16 |
| Model Number | 1-2174 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 796017 |
| Manufacturer | COMPUTERIZED MEDICAL SYSTEMS, INC. |
| Manufacturer Address | * ST. LOUIS MO * US |
| Baseline Brand Name | ACCUSEED DS |
| Baseline Generic Name | BRACHYTHERAPY STEPPER/STABILIZER |
| Baseline Model No | 1-2174 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-16 |