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 2009-07-27 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc.
[15557161]
It was reported that during a liver biopsy procedure, there was an air leak. Another device was used to complete the case. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[15891778]
(b) (4). (b) (4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 3005075853-2009-04381 |
MDR Report Key | 1484666 |
Report Source | 01,05,06,07 |
Date Received | 2009-07-27 |
Date of Report | 2009-07-01 |
Date of Event | 2009-06-29 |
Date Mfgr Received | 2009-06-30 |
Date Added to Maude | 2010-05-27 |
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 | PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH |
Product Code | FDP |
Date Received | 2009-07-27 |
Model Number | NA |
Catalog Number | PN120 |
Lot Number | F4MZ2V |
ID Number | BATCH # 18478 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | NA |
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 | 2009-07-27 |