MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-02 for VERESS NEEDLE 8302.12 N/A manufactured by Richard Wolf Medical Instruments Corp..
[658]
Laproscopic because of possible ectopic pregnancy. It was necessary to repair the common ileac crest and the inferior vena cava. Other equipment being used were a richard wolf co2 insuffalator, and a richard wolf 5mm laproscope. The physician has stated that he feels there was no equipment involvement in the reported incidentdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: manufacturer. Service records not available. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
[2413]
It was necessary to repair the common ileac crest and the inferior vena cava. Other equipment being used were a richard wolf c02 insufflator and a richard wolf laparascopedevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device not serviced in accordance with service schedule. No data - regarding date last serviced. Service provided by: manufacturer. Service records not available. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 760 |
| MDR Report Key | 760 |
| Date Received | 1992-03-02 |
| Date of Report | 1992-02-19 |
| Date of Event | 1992-02-01 |
| Date Facility Aware | 1992-02-01 |
| Report Date | 1992-02-19 |
| Date Reported to FDA | 1992-02-19 |
| Date Reported to Mfgr | 1992-02-10 |
| Date Added to Maude | 1992-06-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VERESS NEEDLE |
| Generic Name | N/A |
| Product Code | FHR |
| Date Received | 1992-03-02 |
| Model Number | 8302.12 |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 745 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-03-02 |