MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-04-11 for PNEUMOPERITONEUM INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[10718791]
(b)(4). Attempts have been made to have device returned. Device location is unknown. No protocols, defects, or non-conformances related to complaint issue were noted. The product met all in-process and finished goods specifications upon release of the product.
Patient Sequence No: 1, Text Type: N, H10
[21266776]
It was reported that prior to an unknown procedure, when opening product it was realized that the seal was not intact.
Patient Sequence No: 1, Text Type: D, B5
[21406105]
(b)(4): information was not provided by the initial contact. Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2013-01733 |
| MDR Report Key | 3052892 |
| Report Source | 01,07 |
| Date Received | 2013-04-11 |
| Date of Report | 2013-03-25 |
| Date of Event | 2013-03-11 |
| Date Mfgr Received | 2013-04-23 |
| Date Added to Maude | 2013-06-17 |
| 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 | 3 |
| 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 | 2013-04-11 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | J4CR3F |
| ID Number | BATCH # NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2013-04-11 |