MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-11-30 for HULKA FALLOPIAN TUBE CLIP 4986.09 manufactured by Richard Wolf Medical Instruments.
[549512]
During tubal sterilization procedure doctor and problems using fallopian tube clips (lot# 1334). Tried using two different sets and all were defective. The clip would not spring back when applied and one clip came apart and fell into the patient's cavity. The clip was removed without any patient injury. Doctors used a different lot # of clips to finish the procedure. No further complications was noted.
Patient Sequence No: 1, Text Type: D, B5
[7939600]
Evaluation summary: 4986. 09 hulka fallopian tube clip. We received one (1) box, containing seven (7) packages of two (2) clips. There was no apparent damaged noticed upon visual examination. During mechanical evaluation, all clips failed drop jaw testing, meaning the upper jaw of the clip did not pivot freely. See attached copy of evaluation report. Production was advised to be more careful with device assembly. Conclusion: device failure directly contributed to the adverse event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2004-00037 |
| MDR Report Key | 803698 |
| Report Source | 05,06 |
| Date Received | 2004-11-30 |
| Date of Report | 2004-11-30 |
| Date of Event | 2004-11-10 |
| Date Facility Aware | 2004-11-10 |
| Report Date | 2004-11-30 |
| Date Mfgr Received | 2004-11-19 |
| Device Manufacturer Date | 2004-08-01 |
| Date Added to Maude | 2007-01-16 |
| 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 PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2004-11-30 |
| Returned To Mfg | 2004-11-19 |
| Model Number | 4986.09 |
| Catalog Number | 4986.09 |
| Lot Number | 1334 |
| ID Number | * |
| Device Expiration Date | 2006-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 791202 |
| 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 | 2004-11-30 |