MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-17 for PNEUMOPERITONEUM INSUFFLATION NEEDLE - 120MM LENGTH PN120 manufactured by Ethicon Endo-surgery, Llc..
[73119990]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73119991]
It was reported that during a robotic assisted hernia repair the surgeon said when the tubing is attached to the device it bends it just enough that the safety device does not snap into place like it should. The procedure was completed using the same device after the surgeon was able to move it to the point where it clicked into place. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
[74278789]
(b)(4). The analysis results found that the pn120 device was received with no damage in the external components. In an attempt to replicate the reported incident, the device was tested for functionality. Upon functional testing; the device work as intended. The instrument was fully functional and conforming to our manufacturing requirements. No conclusion could be reached as to what may have caused the reported incident. We did not receive a batch or lot number for the product involved in this complaint. Therefore, we were unable to check manufacturing records for any related non-conformances.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2017-02118 |
| MDR Report Key | 6498916 |
| Date Received | 2017-04-17 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-04-10 |
| Date Mfgr Received | 2017-04-25 |
| Date Added to Maude | 2017-04-17 |
| 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 | 3 |
| Manufacturer Contact | MILTON GARRETT |
| Manufacturer Street | 4545 CREEK ROAD ML 120A |
| Manufacturer City | CINCINNATI OH 45242 |
| Manufacturer Country | US |
| Manufacturer Postal | 45242 |
| Manufacturer Phone | 5133378865 |
| 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 - 120MM LENGTH |
| Product Code | FDP |
| Date Received | 2017-04-17 |
| Returned To Mfg | 2017-04-24 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | 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 | 2017-04-17 |