MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-09-10 for PNEUMOPERITONEUM NDL PN150 manufactured by Ethicon Endo-surgery, Llc..
[17893556]
It was reported that during a laparoscopic assisted vaginal hysterectomy procedure, fluid was not able to be passed through the needle from the syringe. Another device was used to complete the procedure. No adverse consequences reported.
Patient Sequence No: 1, Text Type: D, B5
[17915825]
(b)(4). The instrument was returned intact for analysis with a syringe full of saline attached to the luer lock of the device. Based upon the inquiry information received and visual examination, it was concluded, the device was blocked by excess adhesive from manufacturing. The batch record was reviewed and no anomalies were noted during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-05191 |
| MDR Report Key | 1830304 |
| Report Source | 07 |
| Date Received | 2010-09-10 |
| Date of Report | 2010-08-16 |
| Date of Event | 2010-08-16 |
| Date Mfgr Received | 2010-08-16 |
| Device Manufacturer Date | 2010-07-11 |
| Date Added to Maude | 2010-11-23 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 NDL |
| Generic Name | PNEUMOPERITONEUM NDL |
| Product Code | FDP |
| Date Received | 2010-09-10 |
| Returned To Mfg | 2010-09-07 |
| Model Number | NA |
| Catalog Number | PN150 |
| Lot Number | G4TF11 |
| ID Number | BATCH # 23890 |
| Device Expiration Date | 2015-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2010-09-10 |