MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-23 for HULKA FALLOPIAN TUBE CLIP 4986.09 manufactured by Richard Wolf Medical Instruments.
[885058]
During a tubal procedure, the fallopian tube clip was being applied. The clip did not close properly. The metal spring (metallic piece of clip) came off in the pt. The spring was removed with an atraumatic grasper forceps. No other clip was applied to the fallopian tube. The method of tubal procedure was changed to cauterizing with kleppinger forceps. There was approx one half hour longer with the surgery. No pt consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[8075736]
Eval summary: the user facility returned the actual fallopian tube clip that was retrieved from the pt and additionally, the remaining clips from the specific lot number. The plastic jaw components and the metal springs were found to be within dimensional and physical tests specification. There was no damage to any of the components. The user facility has only two applicators for tubal procedures but declined to send any applicator in for test and inspection. The user facility was given a replacement box of clips. Cause of event: no conclusion can be drawn. The richard wolf technical manual includes caution when used for pts with adhesions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2008-00019 |
| MDR Report Key | 1082757 |
| Report Source | 06 |
| Date Received | 2008-07-23 |
| Date of Report | 2008-07-22 |
| Date of Event | 2008-06-26 |
| Date Mfgr Received | 2008-06-26 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2008-10-08 |
| 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 |
| 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 | 2008-07-23 |
| Returned To Mfg | 2008-07-01 |
| Model Number | 4986.09 |
| Catalog Number | 4986.09 |
| Lot Number | 1388 |
| Device Expiration Date | 2009-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1220619 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL 60061 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-23 |