MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2010-03-05 for PNEUMOPERITONEUM INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[1420539]
It was reported that during a laparoscopic nissen procedure, the flow of gas was obstructed and could not flow normally due to the opening of the valve being on the wrong side than where it was supposed to be. Another device was used to complete the procedure. There were no adverse consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
[8519016]
(b)(4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-01072 |
| MDR Report Key | 1622624 |
| Report Source | 01,05,06,07 |
| Date Received | 2010-03-05 |
| Date of Report | 2010-02-10 |
| Date of Event | 2010-01-19 |
| Date Mfgr Received | 2010-02-08 |
| Date Added to Maude | 2010-11-29 |
| 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 | 2010-03-05 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | F4PK2T |
| 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 | 2010-03-05 |