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 2009-08-24 for ENDOPATH PNEUMOPERITONEUM NDL PN150 manufactured by Ethicon Endo-surgery, Llc.
[21324969]
Date sent: 06/09/2009. Information is unavailable; device was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[21427447]
It was reported that during a laparoscopic tubal procedure, the first and second device would not allow anything to go thru them. A third device was used to complete the case with no pt consequence. Two devices were discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2009-03392 |
| MDR Report Key | 1446703 |
| Report Source | 05,06,07 |
| Date Received | 2009-08-24 |
| Date of Report | 2009-05-28 |
| Date of Event | 2009-05-26 |
| Date Mfgr Received | 2009-05-28 |
| Device Manufacturer Date | 2008-09-01 |
| Date Added to Maude | 2009-09-11 |
| 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 | 3 |
| 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 Country | US |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH PNEUMOPERITONEUM NDL |
| Generic Name | FDP |
| Product Code | FDP |
| Date Received | 2009-08-24 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | E4M22T |
| ID Number | BATCH #NA |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | GUAYNABO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-24 |