MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-01-13 for HULKA FALLOPIAN TUBE CLIP 4986.90 manufactured by Richard Wolf Medical Instruments.
[1064928]
It was reported by the surgeon that during a tubal sterilization procedure, the spring from the clip fell in the pelvis cavity of the pt. The spring was not retrieved. The procedure was completed without any consequences.
Patient Sequence No: 1, Text Type: D, B5
[8256139]
(b)(6). The hulka clip without spring is not available for eval. The customer has used 50% of the clips from this lot # 1392 without incident. The end user informed richard wolf that a tubal procedure was completed the next day on another pt with the same lot # and there were not problems. The end user informed richard wolf that their hulka clip applicator is also working well. The exact cause of the spring falling in the pt is unk. Should there be additional info, a f/u report will be completed. Richard wolf medical has none of this lot # 1392 in inventory.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2009-00002 |
| MDR Report Key | 1357081 |
| Report Source | 05,06 |
| Date Received | 2009-01-13 |
| Date of Report | 2009-01-13 |
| Date of Event | 2008-12-22 |
| Date Mfgr Received | 2008-12-22 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2009-10-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HULKA FALLOPIAN TUBE CLIP |
| Generic Name | HULKA FALLOPIAN TUBE CLIP |
| Product Code | HGB |
| Date Received | 2009-01-13 |
| Model Number | 4986.90 |
| Catalog Number | 4986.90 |
| Lot Number | 1392 |
| Device Expiration Date | 2010-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-01-13 |