MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-20 for VARIES NEEDLE 26120 manufactured by Storz Instruments Co..
[12653]
The needle was inserted into the abdomen at the incision site for a laparoscopy. Once the needle was in place, carbon dioxide was infused through cannula into the abdominal cavity. When the cannula was removed it appeared that a piece was missing from the inner stylus. The surgeon located the missing piece at the incision site and removed it. No injury was sustained as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003736 |
| MDR Report Key | 17001 |
| Date Received | 1994-10-20 |
| Date of Report | 1994-10-06 |
| Date of Event | 1994-09-30 |
| Date Added to Maude | 1994-10-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARIES NEEDLE |
| Generic Name | LAPAROSCOPY INSTRUMENT |
| Product Code | FHP |
| Date Received | 1994-10-20 |
| Model Number | 26120 |
| Catalog Number | 26120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16934 |
| Manufacturer | STORZ INSTRUMENTS CO. |
| Manufacturer Address | ST LOUIS MO 63122 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-10-20 |