MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1998-10-23 for ENDOPATH ULTRA VERESS NEEDLE * manufactured by Symbiosis Corp..
[119275]
It was reported by the sales rep the device was used during a laparoscopic cholecystectomy. It was reported "a surgeon stuck the right iliac artery upon insertion of the uv120 veress needle. " she reported to the rep she did not believe the problem was a result of the product, but rather the surgeon's technique. She asked to have the product evaluated. Case was converted to open. Sales rep also forwarded medwatch form, unnumbered, completed by account which states "patient for laparoscopic cholecystectomy. Upon insertion of veress needle, right iliac artery was punctured. Laparotomy was performed for repair of artery and cholecystectomy performed open. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527736-1998-03105 |
| MDR Report Key | 193094 |
| Report Source | 07 |
| Date Received | 1998-10-23 |
| Date of Event | 1998-09-16 |
| Date Mfgr Received | 1998-09-24 |
| Device Manufacturer Date | 1998-07-01 |
| Date Added to Maude | 1998-10-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH ULTRA VERESS NEEDLE |
| Generic Name | INSUFFLATION NEEDLES |
| Product Code | FHP |
| Date Received | 1998-10-23 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | L4AN6U |
| ID Number | NA |
| Device Expiration Date | 2003-06-21 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 187627 |
| Manufacturer | SYMBIOSIS CORP. |
| Manufacturer Address | 8600 NW 41ST ST MIAMI FL 33166 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-10-23 |