MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-07-06 for PNEUMOPERITONEUM INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[20070785]
It was reported that during an unknown procedure, the device was not retracting and the red part at the top of the device was showing. The surgeon was concerned the device could puncture bowel. Another device was used to complete the procedure. There were no adverse consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
[20430087]
(b)(4): information not available, device not returned for analysis. Should the information be provided later, a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005075853-2015-04071 |
| MDR Report Key | 4892700 |
| Report Source | 06,07 |
| Date Received | 2015-07-06 |
| Date of Report | 2015-06-30 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 |
| Generic Name | INSUFFLATION NEEDLE |
| Product Code | FDP |
| Date Received | 2015-07-06 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | M4HL6R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-07-06 |