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 2010-03-30 for PNEUMOPERITONEUM INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[18512132]
It was reported that prior to a laparoscopic cholecystectomy procedure, before inserting the needle, it was tested with water. The water would not pass through the needle. A new needle was pulled and used. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[18595820]
(b)(4): information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-01545 |
| MDR Report Key | 1644448 |
| Report Source | 05,06,07 |
| Date Received | 2010-03-30 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-02-02 |
| Date Mfgr Received | 2010-03-04 |
| Date Added to Maude | 2010-08-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHY RICE |
| Manufacturer Street | 4545 CREEK RD |
| Manufacturer City | CINCINNATI OH 452422803 |
| Manufacturer Country | US |
| Manufacturer Postal | 452422803 |
| Manufacturer Phone | 5133373299 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO PR 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUMOPERITONEUM INSUFFLATION NEEDLE |
| Product Code | FDP |
| Date Received | 2010-03-30 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | UNK |
| ID Number | BATCH # NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Address | 475 CALLE C GUAYNABO PR 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-30 |