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 2010-04-13 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc..
[1581411]
It was reported that during an unknown procedure, the surgeon was unable to get pneumo using the device. The device did not allow the co2 to flow into the patient. There were no patient consequences. Case completed with another device of the same product code.
Patient Sequence No: 1, Text Type: D, B5
[8545729]
(b)(4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-01874 |
| MDR Report Key | 1657474 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-13 |
| Date of Report | 2010-04-08 |
| Date Mfgr Received | 2010-03-01 |
| Date Added to Maude | 2010-12-01 |
| 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 - 120MM LENGTH |
| Generic Name | INSUFFLATION NEEDLE |
| Product Code | FDP |
| Date Received | 2010-04-13 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | F4PV1J |
| 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 | 2010-04-13 |