D
Patient 1
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.
MAUDE MDR 167944
- MDR report key
- 167944
- Report number
- 2124979-1998-00005
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-04-09
- Date received
- 1998-05-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 500
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BERKELEY VACURETTE F-TIP 6MM | FLEXIBLE TIP CURETTE | CIRCON SURGITEK | HHK | NA | 21665 | 4M1082 | N | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1998-05-15 | 0 | 1. R |
Event Narratives#
N
Patient 1
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."