MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for CHOLECYSTECTOMY TRAY LCB52S manufactured by Ethicon Endo Surgery, Inc (cincinnati).
[70408613]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[70408614]
It was reported by the customer that before an unknown procedure, the customer found a hole in the sterile packaging for the entire tray. Procedure was completed with another device of the same product code. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
[73178139]
(b)(4). Batch # n9328g, n9320k, n9323w. Packaging lot# n93487, manufactured date: 10/18/2016 product exp. Date: 9/30/2021. Packaging lot# n9353g, manufactured date: 10/19/2016 product exp. Date: 9/30/2021. The analysis results found that the lcb52s devices were returned outside its original package. Only the devices from the cholecystectomy tray were received. It could not be determined 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 | 1527736-2017-00005 |
| MDR Report Key | 6411700 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2017-03-29 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2017-03-16 |
| 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 | 2017-03-16 |
| Returned To Mfg | 2017-03-28 |
| Model Number | NA |
| Catalog Number | LCB52S |
| 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, INC (CINCINNATI) |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 452422803 US 452422803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-16 |