MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-07 for CAPTUS 3000 manufactured by Capintec, Inc..
[4351927]
Technologist reported that she was positioning the collimator, which houses the detector of the captus 3000, over the pt's leg to perform a measurement. The collimator detached from the arm, and hit the pt near the knee area. The signal, cable remained attached. The pt experienced swelling, was treated with ice an sent to the ed for eval. X-rays were negative for fracture, and the pt was sent home.
Patient Sequence No: 1, Text Type: D, B5
[11650849]
History of the system involved in the complaint. On (b)(6) 2011, the system was upgraded at the customer's request to a captus 3000 (cnv 712). Because the system was more than 10 years old, the upgrade included a new collimator receptacle, captive spring plunger and snap ring, which together support the collimator. All of these components were installed by the customer's biomedical engineering department. On (b)(6) 2012, customer purchased another collimator receptacle, captive spring plunger and snap ring, as well as two kinds located on the collimator receptacle. On (b)(6) 2012, customer purchased two knobs located on the spring arm. On (b)(6) 2013, someone from the customer's biomedical engineering department called stating unit indicated wear. At that time, customer ordered another collimator, collimator receptacle, and captive spring plunger. On (b)(6) 2013, customer ordered another four plastic knobs. On (b)(6) 2013, customer ordered detector signal cable. On (b)(6) 2013, (b)(4), customer's chief technologist, called to report the above incident. Note: capintec has requested return of suspect device on multiple occasions, but has not yet received it. Therefore, complete eval and failure analysis cannot be performed unless/until the device is returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518443-2013-00001 |
| MDR Report Key | 3650489 |
| Report Source | 05,06 |
| Date Received | 2014-01-07 |
| Date of Report | 2014-01-06 |
| Date of Event | 2013-12-11 |
| Date Mfgr Received | 2013-12-11 |
| Device Manufacturer Date | 2000-11-01 |
| Date Added to Maude | 2014-04-09 |
| 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 |
| Reporter Occupation | NUCLEAR MEDICINE TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARY YUSKO |
| Manufacturer Street | 620 ALPHA DR. |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal | 15238 |
| Manufacturer Phone | 4129631988 |
| Manufacturer G1 | CAPINTEC, INC. |
| Manufacturer Street | 620 ALPHA DR. |
| Manufacturer City | PITTSBURGH PA 15238 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 15238 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPTUS 3000 |
| Generic Name | THYROID UPTAKE SYSTEM |
| Product Code | IZD |
| Date Received | 2014-01-07 |
| Model Number | CAPTUS 3000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAPINTEC, INC. |
| Manufacturer Address | 6 ARROW DRIVE RAMSEY NJ 07446 US 07446 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-07 |