MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-03-17 for BERKELEY VACURETTE 8MM F-SET 53158 manufactured by Circon Surgitek.
[7766249]
An inspection of the device associated with the incident was conducted. The distal tip of the device was not returned. The portion of the device that was returned was torn at the point between the distal and proximal suction ports. The tear appears to have started at the sharp point of the proximal suction port and propagated through the vacurette to the bottom of the distal suction port. This is the thinnist point of the device cross-section. There were no signs of cutting or melting of the device. The device has yellowed or become brittle and all other aspects of the unit have remained unchanged. In addition to the visual examination of the returned device, pull strength testing of the suction ports of the 8 mm f-tip was performed on product in inventory. The results of this testing showed the average pull strength for the distal port to be 14. 14 lbs (one standard deviation = 1. 64 lbs) and the average pull strength for the proximal port to be 22. 66 lbs (one standard deviation = 1. 86 lbs). An illustration of the device and test configuration is included in this submission.
Patient Sequence No: 1, Text Type: N, H10
[15482680]
When pulling the f-tip vacurette out of the uterus during a vacuum curretage procedure, the tip got stuck. The dr pulled harder and was able to remove the f-tip vacurette. When the vacurette was removed from the uterus it was noted that the tip was missing. A d & c was performed and the tip could not be found. It is assumed that the tip is embedded in the uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124979-1998-00002 |
| MDR Report Key | 158410 |
| Report Source | 05 |
| Date Received | 1998-03-17 |
| Date of Report | 1998-02-27 |
| Date of Event | 1998-02-27 |
| Date Mfgr Received | 1998-02-27 |
| Device Manufacturer Date | 1994-04-01 |
| Date Added to Maude | 1998-03-25 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERKELEY VACURETTE 8MM F-SET |
| Generic Name | FLEXIBLE TIP VACURETTE |
| Product Code | HHK |
| Date Received | 1998-03-17 |
| Model Number | NA |
| Catalog Number | 53158 |
| Lot Number | 4D1031 |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 154308 |
| Manufacturer | CIRCON SURGITEK |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | BERKELEY VACURETTE 8MM F-SET |
| Baseline Generic Name | FLEXIBLE TIP VACURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 53158 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-17 |