MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-03-19 for PNEUMOPERITONEUM INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[2408892]
It was reported that during the procedure, air entered into the thoracic cavity from the t shape stopcock when the device was used for drainage of pleural effusion. As a result, the patient's hospitalization was extended by one day. The air is still inside the thoracic cavity.
Patient Sequence No: 1, Text Type: D, B5
[9696860]
(b)(4). Information anticipated, but unavailable at this time. The event was reviewed with an ees cross-functional team consisting of cq, marketing, risk management, medical affairs, and engineering. Additional questions and clarification were requested and the following was provided by the affiliate: the intent of this product is to establish pneumoperitoneum. Was the device being used off label? ---the doctor said that the pneumo- means lung. Therefore the doctor used the device for drainage of pleural effusion. For your information, our sales rep told the doctor that the intent of the device is to establish pneumoperitoneum. Is it common practice with this surgeon and/or account to use a pn120 for drainage of pleural effusion? ---yes. What devices are typically used for draining pleural effusions? ---the device was used for drainage over 10 years. What was the intent of the use of this device during this procedure? ---for drainage. The stopcock was connected to tube and syringe, and then pleural effusion was aspirated. Please provide specifics around any quality issue being reported for the pn120? --- the doctor commented that there was no anomalies noted for visual and functional. Was the stopcock in the open or closed position? ---the stopcock was in the open position. Is the patient expected to have a full recovery? ---yes. What is the patient's current status? ---well. What is the patient's sex, age, and weight? ---patient id (b)(6), sex male, (b)(6) , history pneumoconiosis, benign asbestosis, thoracoscopy of right lung. In addition, a copy of the instructions for use were sent with the request for additional details.
Patient Sequence No: 1, Text Type: N, H10
[17086931]
(b)(4). The device was returned for analysis with dried body fluids on the needle. Based upon the visual and functional examination, it was concluded that the air flow and return spring force were normal the device is fully conforming. Analysis of the device found it fully functional. Unable to confirm customer's complaint. The batch record was reviewed and no anomalies were noted during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2012-01214 |
| MDR Report Key | 2495335 |
| Report Source | 01,07 |
| Date Received | 2012-03-19 |
| Date of Report | 2012-02-22 |
| Date of Event | 2012-02-16 |
| Date Mfgr Received | 2012-04-17 |
| Date Added to Maude | 2012-03-19 |
| 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 | 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 | PNEUMOPERITONEUM INSUFFLATION NEEDLE |
| Generic Name | PNEUMOPERITONEUM INSUFFLATION NEEDLE |
| Product Code | FDP |
| Date Received | 2012-03-19 |
| Returned To Mfg | 2012-04-05 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | NI |
| ID Number | BATCH # 30956 |
| 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 | 1. Required No Informationntervention | 2012-03-19 |