MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-21 for PNEUMOPERITONEUM INSUFFLATION NEEDLE PN120 manufactured by Ethicon Endo-surgery, Llc..
[22567267]
(b)(4). Information asked for but unknown or not provided during initial contact. No device received for analysis at time of submission of 3500a. When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[22567388]
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
[27663919]
(b)(4). Conclusion: the devices that were returned were not the device used. No conclusion could be reached or the complaint confirmed without the needle that was used returned for analysis. We did not receive a valid 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 | 3005075853-2015-04454 |
| MDR Report Key | 4929608 |
| Date Received | 2015-07-21 |
| Date of Report | 2015-06-30 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-07-31 |
| Date Added to Maude | 2015-07-21 |
| 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 |
| Product Code | FDP |
| Date Received | 2015-07-21 |
| Returned To Mfg | 2015-07-22 |
| Model Number | NA |
| Catalog Number | PN120 |
| Lot Number | M4HL6R |
| 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 | 2015-07-21 |