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 2015-03-23 for PNEUMOPERITONEUM NEEDLE PN150 manufactured by Ethicon Endo-surgery, Llc..
[5586774]
It was reported that during an unknown procedure, the product does not have normal spring action. It is unknown what was used to complete the procedure. There were no adverse consequences for the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[13119159]
(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
[13154349]
(b)(4). Additional information: the instrument product code pn150 was returned intact with the tyvek packaging for analysis. Based upon the visual and functional examination, we were unable to determine the cause of the friction. Disassembly of the device did not identify the cause. No obvious burrs or bends causing the interference. The batch history records were reviewed by the harmac manufacturing engineer with no anomalies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2015-01759 |
| MDR Report Key | 4623182 |
| Report Source | 01,06,07 |
| Date Received | 2015-03-23 |
| Date of Report | 2015-03-05 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-04-17 |
| Date Added to Maude | 2015-04-23 |
| 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 |
| Brand Name | PNEUMOPERITONEUM NEEDLE |
| Product Code | FDP |
| Date Received | 2015-03-23 |
| Returned To Mfg | 2015-04-06 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | L4FH1U |
| 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 | 2015-03-23 |