MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-14 for CHOLECYSTECTOMY TRAY FNC42XL manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[48315162]
(b)(4) date sent: 6/14/2016 attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. The device history records were reviewed and the packaging criteria were met prior to the release of this lot.
Patient Sequence No: 1, Text Type: N, H10
[48315163]
It was reported that prior to an unknown procedure during stock check, the lap-chole tray (sterile packed) was found to be unsterile with compromised integrity of outer plastic cover. It is unknown what was used to complete the procedure. There were no adverse consequences for the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[48315857]
(b)(4). Date sent: 6/27/2016. The devices from the fnc42xl were returned for analysis. The primary package was not received for analysis. We were unable to evaluate the reported condition as the fnc42xl package was not returned for analysis. It could not be determine what may have cause the reported event. The lot history record was reviewed and no defects, ncr? S or protocols related to the complaint, were found during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1527736-2016-00016 |
| MDR Report Key | 5724174 |
| Date Received | 2016-06-14 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-05-24 |
| Date Mfgr Received | 2016-06-22 |
| Device Manufacturer Date | 2015-10-22 |
| Date Added to Maude | 2016-06-14 |
| 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, INC. (ALBUQUERQUE) |
| Manufacturer Street | 3801 UNIVERSITY BLVD SE |
| Manufacturer City | ALBUQUERQUE NM 871065605 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 871065605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLECYSTECTOMY TRAY |
| Generic Name | CHOLECYSTECTOMY TRAY |
| Product Code | PKE |
| Date Received | 2016-06-14 |
| Returned To Mfg | 2016-06-16 |
| Model Number | NA |
| Catalog Number | FNC42XL |
| Lot Number | M9325U |
| 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, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 452422803 US 452422803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-14 |