MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-10-08 for PNEUMOPERITONEUM INSUFFLATION PN120 manufactured by Ethicon Endo-surgery, Llc..
[1464080]
It was reported that during a laparoscopic cholecystectomy procedure, the device would not allow the co2 to flow through the needle. Another device was used to complete the case with no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
[8709962]
(b)(4). Information anticipated, but unavailable at this time.
Patient Sequence No: 1, Text Type: N, H10
[16108294]
The pt's father reported that it takes several button presses to activate pump functions. The issue reportedly began in (b)(6) 2010, and progressively got worse over time. The reporter believed that the issue was due to general wear.
Patient Sequence No: 1, Text Type: D, B5
[16119946]
(b)(4). The instrument was received in good condition, with dried body fluids. Based upon the inquiry information received and visual examination, it was concluded, the device was tested and air flows through the device. The device was fully functional and conforming to design specifications. Analysis found the air flows through the device normally. The instrument is fully functional. The customers complaint could not be confirmed. The batch record was reviewed and no anomalies were noted during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2010-05776 |
| MDR Report Key | 1862102 |
| Report Source | * |
| Date Received | 2010-10-08 |
| Date of Report | 2010-09-16 |
| Date of Event | 2010-09-16 |
| Date Mfgr Received | 2010-12-16 |
| Date Added to Maude | 2010-12-27 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PNEUMOPERITONEUM INSUFFLATION |
| Product Code | FDP |
| Date Received | 2010-10-08 |
| Returned To Mfg | 2010-10-05 |
| Catalog Number | PN120 |
| Lot Number | G4T15J |
| ID Number | 23929 |
| 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 | 2010-10-08 |