MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-05-15 for BERKELEY VACURETTE F-TIP 6MM 21665 manufactured by Circon Surgitek.
[97267]
During an incision and drainage the f-tip perforated the uterine wall. The f-tip became caught on the uterine wall and broke when trying to remove it. The tip fell off out of the uterus and was removed laparoscopically.
Patient Sequence No: 1, Text Type: D, B5
[7774320]
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 second suction port (approximately 5/8" from the distal tip). There are no defects in the tubing or the suction ports. Analysis of the failed joint indicates that the plastic tube failed in tear rather than tensile. The mode of failure was duplicated with a 6mm f-tip from inventory. The f-tip was bent to one side at the second suction port and then pulled. The f-tip bent at the side and was torn off. This failure was compared to the returned sample and found to look identical. In addition to the visual examination of the returned device, pull strength testing of the suction ports of the 6mm f-tip was performed on product in inventory. The results of this testing showed the average pull strength for the distal port to be 9. 37 lbs (one standard deviation = 0. 95) and the average pull strength for the proximal port to be 15. 78 lbs ( one standard deviation = 1. 07). The discrepancy exhibited between the pull strength results of the proximal and distal ports can be attributed to the fixture used to pull test the units. The hook on the fixture interfered with the distal end of the f-tip when the distal suction port was being tested. This interference could have given lower pull values than would be necessary for failure in pt use. An illustration of the device and test configuration is included in this submission. In response to this incident, a package insert is now included with the product stating "caution: do not apply excessive force while using these probes. Excessive pushing, bending or pulling could result in breakage of the device and/or injury to the pt. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2124979-1998-00005 |
| MDR Report Key | 167944 |
| Report Source | 05 |
| Date Received | 1998-05-15 |
| Date of Report | 1998-04-16 |
| Date of Event | 1998-04-09 |
| Date Mfgr Received | 1998-04-16 |
| Device Manufacturer Date | 1994-12-01 |
| Date Added to Maude | 1998-05-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 F-TIP 6MM |
| Generic Name | FLEXIBLE TIP CURETTE |
| Product Code | HHK |
| Date Received | 1998-05-15 |
| Model Number | NA |
| Catalog Number | 21665 |
| Lot Number | 4M1082 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 163411 |
| Manufacturer | CIRCON SURGITEK |
| Manufacturer Address | 3037 MT. PLEASANT ST. RACINE WI 53404 US |
| Baseline Brand Name | BERKELEY VACURETTE CANNULA, F-TIP |
| Baseline Generic Name | FLEXIBLE TIP CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 21665 |
| Baseline ID | F-TIP VACURETTE |
| Baseline Device Family | F-TIP VACURETTE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-05-15 |