MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-11-24 for HULKA FALLOPIAN TUBE CLIP 4986.09 manufactured by Richard Wolf Medical Instruments.
[588758]
Doctor was doing a laparoscopic tubal ligation using hulks clips. When the doctor went to implant the first clip on the fallopian tube, the hulka applicator closed, but when the clip was released, it fell off the fallopian tube, due to clip not being completely closed. The hulka clip fell into the patient's cavity, but the doctor was able to retrieve the clip with a grasper. When removing the clip through the trocar port, the doctor had to make a larger incision to get the clip out of the patient. The clip came apart while doctor was removing it through the trocar port, but all pieces were retrieved without any patient injury or complications. Another clip was applied successfully.
Patient Sequence No: 1, Text Type: D, B5
[8058938]
Results of evaluation showed that clip failed pivot test (drap jaw-upper jaw pivots freely). This could have occurred due to rough handling of clip during removal. All other performance test on clip passed. See attached report. Also, hulka clip applicator that was used during procedure was evaluated and there was no problem found with the applicator. No true conclusion can be drawn on why incident happened. Cause could have been related to user handling. Hulka clip applicator (8388. 84) was sent in for evaluation with (2) hulka clips (4986. 09). One of the hulka clips (clip a) was the clip that fell into the patient cavity. Per evaluation, the hulka clip applicator performing to specification and no problem was found. The hulka clips went through performance testing and pass all except the pivot test, which is the drop jaw (upper jaw pivots freely) test. There is no real conclusion that can be drawn, due to the fact that clips were severely bent when it came in for evaluation. The rough handling of both clips could have caused the clips to fail the pivot test. Cause: unk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2004-00034 |
| MDR Report Key | 806336 |
| Report Source | 05,06 |
| Date Received | 2004-11-24 |
| Date of Report | 2004-11-23 |
| Date of Event | 2004-10-29 |
| Date Facility Aware | 2004-10-29 |
| Report Date | 2004-11-23 |
| Date Reported to Mfgr | 2004-11-05 |
| Date Mfgr Received | 2004-11-05 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2007-01-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | IOANA MARTA |
| Manufacturer Street | 353 CORPORATE WOODS DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HULKA FALLOPIAN TUBE CLIP |
| Generic Name | FALLOPIAN TUBE CLIP |
| Product Code | HGB |
| Date Received | 2004-11-24 |
| Returned To Mfg | 2004-11-05 |
| Model Number | 4986.09 |
| Catalog Number | 4986.09 |
| Lot Number | 1329 |
| ID Number | NA |
| Device Expiration Date | 2006-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 793849 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | * VERNON HILLS IL 60061 US |
| Baseline Brand Name | HULKA FALLOPIAN TUBE CLIP |
| Baseline Generic Name | FALLOPIAN TUBE CLIP |
| Baseline Model No | 4986.09 |
| Baseline Catalog No | 4986.09 |
| Baseline ID | 1220 |
| Baseline Device Family | TUBAL OCCLUSION CLIP |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | Y |
| Premarket Approval | P8700 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-24 |