MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-07-09 for INSUFFLATION & ACCESS NEEDLE, 14G RS100000 manufactured by United States Surgical Corporation.
[20681639]
Reportedly, the tip of the insufflation needle broke off and fell into the patient's cavity. The tip was laparoscopically retrieved. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2001-00376 |
| MDR Report Key | 342080 |
| Report Source | 05,06,07 |
| Date Received | 2001-07-09 |
| Date of Report | 2001-06-14 |
| Date of Event | 2001-05-29 |
| Date Facility Aware | 2001-05-29 |
| Date Mfgr Received | 2001-06-14 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2001-07-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA POEPE, RN, MA, CEN |
| Manufacturer Street | 195 MCDERMOT ROAD |
| 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 | INSUFFLATION & ACCESS NEEDLE, 14G |
| Generic Name | * |
| Product Code | FHO |
| Date Received | 2001-07-09 |
| Returned To Mfg | 2001-06-19 |
| Model Number | NA |
| Catalog Number | RS100000 |
| Lot Number | P1C621 |
| ID Number | NA |
| Device Expiration Date | 2006-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 331414 |
| Manufacturer | UNITED STATES SURGICAL CORPORATION |
| 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 | 2001-07-09 |