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 2011-01-12 for INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[1791950]
It was reported that during an unknown procedure, the device was used as a pneumoperitoneum needle. When normal saline was going to be injected into the patient's body through the device to confirm whether it arrived at the peritoneum, the normal saline could not be injected into the patient's body through the device. Another device was used to complete the case. There were no adverse consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
[8869554]
(b)(4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
[9221228]
(b)(4). Based upon the visual and functional examination, it was concluded that the needle was blocked due to excess adhesive used in manufacturing of the device. The batch history records were reviewed with no anomalies noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2011-00131 |
| MDR Report Key | 1958950 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-01-12 |
| Date of Report | 2010-12-16 |
| Date of Event | 2010-12-10 |
| Date Mfgr Received | 2010-12-15 |
| Date Added to Maude | 2011-11-16 |
| 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 | INSUFFLATION NEEDLE |
| Product Code | FDP |
| Date Received | 2011-01-12 |
| Returned To Mfg | 2011-01-19 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | UNK |
| ID Number | BATCH # UNK |
| 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 | 2011-01-12 |