MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2002-09-26 for REPOSABLE INSUFFLATION/ACCESS NEEDLE 14G RS100000 manufactured by Ponce - Uss.
[258291]
Procedure: hysterectomy. During assembly of the instrument and insertion of the needle, the tip of the needle bent. The surgeon opted to perform an open procedure vs. A laparoscopically assisted vaginal hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2002-00203 |
| MDR Report Key | 419563 |
| Report Source | 01,06,07 |
| Date Received | 2002-09-26 |
| Date of Report | 2002-08-28 |
| Date of Event | 2002-08-19 |
| Date Mfgr Received | 2002-08-28 |
| Date Added to Maude | 2002-10-03 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LAURA SOUSA, RN, MA |
| Manufacturer Street | 195 MCDERMOTT RD. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926334 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REPOSABLE INSUFFLATION/ACCESS NEEDLE 14G |
| Generic Name | SURGICAL INSUFFLATION ACCESS NEEDLE |
| Product Code | FHO |
| Date Received | 2002-09-26 |
| Model Number | NA |
| Catalog Number | RS100000 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 408614 |
| Manufacturer | PONCE - USS |
| Manufacturer Address | SABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US |
| Baseline Brand Name | STEP REPOSABLE INSUFFLATION & ACCESS NEEDLE, 14G |
| Baseline Generic Name | SURGICAL ACCESS DEVICE |
| Baseline Model No | NA |
| Baseline Catalog No | RS100000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-09-26 |