MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-27 for LIGACLIP*ENDO MED/LG APPLIER EL314 manufactured by Ethicon Endo-surgery, Llc..
[101116491]
(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. What were the indications for surgery? What was the manufacture or the product code of the clips used with the el314 device? Was a lc800 loading base used with the cartridges that were used to load the clip applier? What was the vessel that these clips were place on? How many clips were placed on the patient side? Were there any clip formation issues intra-operatively? If yes, please explain. How was the bleeding identified? Can you please provide a time line of events? Was the patient on anticoagulation therapy? Did the patient have a clotting abnormality? Was an autopsy performed? If yes, is the report available? Would the surgeon be willing to speak with ethicon medical and engineering personnel? What was the cause of death? Was an additional surgical procedure done? How was it known that the clip was loose?
Patient Sequence No: 1, Text Type: N, H10
[101116492]
Lap cholecystectomy. The ligaclip (code el314 ) for laparoscopy failed and the clip was loose causing postoperative bleeding. Action taken for procedure: reintervention but the patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2018-08237 |
| MDR Report Key | 7301108 |
| Date Received | 2018-02-27 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-02-02 |
| Date Mfgr Received | 2018-10-02 |
| Device Manufacturer Date | 2012-06-30 |
| Date Added to Maude | 2018-02-27 |
| 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 | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 5133378865 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGACLIP*ENDO MED/LG APPLIER |
| Generic Name | LIGACLIP |
| Product Code | HBT |
| Date Received | 2018-02-27 |
| Returned To Mfg | 2018-10-02 |
| Catalog Number | EL314 |
| Lot Number | NA |
| 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 00969 00969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-27 |