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 |