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 2014-09-18 for ENDOPATH INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[4764354]
It was reported that before an unknown procedure, the needle did not retract when it was tested prior to being used on 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
[12197110]
(b)(4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
[12241308]
(b)(4). Additional information: based upon the visual and functional examination, it was concluded that the device is conforming. Analysis was unable to confirm the customer's complaint. The needle functions normally. The device record was reviewed and no anomalies were noted during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2014-06494 |
| MDR Report Key | 4098565 |
| Report Source | 05,06,07 |
| Date Received | 2014-09-18 |
| Date of Report | 2014-09-08 |
| Date of Event | 2014-07-18 |
| Date Mfgr Received | 2014-09-25 |
| Date Added to Maude | 2014-09-29 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | GUILLERMO VILLA |
| Manufacturer Street | ROUTE 22 WEST PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| 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 | ENDOPATH INSUFFLATION NEEDLE |
| Generic Name | APPARATUS, PNEUMOPERITONEUM, AUTOMATIC |
| Product Code | FDP |
| Date Received | 2014-09-18 |
| Returned To Mfg | 2014-09-24 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | L4EP5N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-09-18 |