MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2009-08-14 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120 MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc.
[1241239]
It was reported that during thoracic surgery, insufflation through needle was not possible. During a thoracentesis, the needle's tap was disconnected. Another device was used to complete the procedure. There was no advise consequences reported.
Patient Sequence No: 1, Text Type: D, B5
[8416978]
(b) (4). (b) (4). Info is unavailable; device was not returned for eval. Eval summary: the complaint could not be confirmed because no device was returned for analysis. We did not receive a batch or lot number for the product involved in this complaint. Therefore, we were unable to check mfg records for any related non-conformances.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2009-04874 |
| MDR Report Key | 1493289 |
| Report Source | 01,07 |
| Date Received | 2009-08-14 |
| Date of Report | 2009-07-22 |
| Date of Event | 2009-07-08 |
| Date Mfgr Received | 2009-07-22 |
| Date Added to Maude | 2009-11-25 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| 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 Country | US |
| 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 INSUFFLATION NEEDLE - 120 MM LENGTH |
| Product Code | FDP |
| Date Received | 2009-08-14 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON ENDO-SURGERY, LLC |
| Manufacturer Address | GUAYNABO PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-14 |