MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-05-01 for TAO BRUSH I.U.M.C ENDOMETRIAL SAMPLER J-ES-090500 manufactured by Cook Urological, Inc..
[853573]
Customer states: "the ball tip of the tao brush had come off inside the patient's uterus, and they knew the tip was on the brush prior to placement. "
Patient Sequence No: 1, Text Type: D, B5
[7998917]
One specimen jar containing the brush portion in fluid and the brush shaft was received. The clear sheath on the shaft was noted to be slid up 3cm from the handle in the open position. The clear sheath was also noted to be separated into two segments with the point of separation to have a twisted appearance. The shaft segment measured 19. 4cm and the brush segment measured 2. 9cm. The wires were noted to be cut below the bristles of the brush; cut marks were visible on the wires on both segments. Cutting the brush off following the procedure is common practice. Upon close examination of the distal end, where the ball tip was located, adhesive was present. The distributor indicated the physician and patient agreed to not remove the ball at the time of the separation; the physician indicated the physician and patient agreed to not remove the ball at the time of the separation; the physician indicated the ball should come out on it's own. The ball tip is made of polythene plastic and is approximately 3mm in diameter. The distributor has been contacted for additional information and has indicated they have not been made aware as to whether the patient has passed the ball tip or not. They also indicated that they were not getting any additional information from the physician. Each brush has the ball tip 100% pull tested during the manufacturing phase to assure the ball is secure prior to packaging. We are unable to determine what has caused the ball to separate from the shaft of the brush. Should additional information become available, it will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825146-2008-00018 |
| MDR Report Key | 1036638 |
| Report Source | 08 |
| Date Received | 2008-05-01 |
| Date Mfgr Received | 2008-04-08 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2008-05-08 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | TAMMY BACON |
| Manufacturer Street | 1100 WEST MORGAN ST. |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal | 47460 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAO BRUSH I.U.M.C ENDOMETRIAL SAMPLER |
| Generic Name | TAO BRUSH |
| Product Code | HHK |
| Date Received | 2008-05-01 |
| Returned To Mfg | 2008-04-14 |
| Model Number | NA |
| Catalog Number | J-ES-090500 |
| Lot Number | U1586825 |
| ID Number | NA |
| Device Expiration Date | 2009-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1005737 |
| Manufacturer | COOK UROLOGICAL, INC. |
| Manufacturer Address | SPENCER IN 47460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-05-01 |