MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-02-17 for PN150 manufactured by Ethicon Endo-surgery, Llc..
[5490447]
It was reported that during an unknown procedure, the spring does not spring back. Procedure completed with same/like device. There was no adverse consequence to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[12933048]
(b)(4). No device received for analysis at time of submission of 3500a. When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[20467135]
(b)(4). Additional information: undetermined cause of rub between the stylet and needle based. Upon the visual and functional examination, it was concluded that the device has a slight rub between the stylet and needle that prevented full return. The cause of the interference is undetermined; disassembly of the device identified no bends or burrs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2015-01127 |
| MDR Report Key | 4521880 |
| Report Source | 01,06,07 |
| Date Received | 2015-02-17 |
| Date of Report | 2015-02-03 |
| Date of Event | 2015-01-28 |
| Date Mfgr Received | 2015-05-01 |
| Device Manufacturer Date | 2014-11-26 |
| Date Added to Maude | 2015-03-19 |
| 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 | 0 |
| 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 |
| Product Code | FDP |
| Date Received | 2015-02-17 |
| Returned To Mfg | 2015-04-13 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | L4FE7K |
| Device Expiration Date | 2019-10-26 |
| 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 | 2015-02-17 |