MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for LIGACLIP*ENDO MED/LG APPLIER EL314 manufactured by Ethicon Endo-surgery, Llc..
[87732628]
(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 is the correct procedure date and what is the correct event date as you have the procedure date as (b)(6) 2017 and the event date as (b)(6) 2017? Was there only one procedure? Or was there a re-operation? If there was a re-operation, what was the reason for re-operation?
Patient Sequence No: 1, Text Type: N, H10
[87732629]
It was reported that during a cholecystectomy, when they clipped the cystic duct the two clips went out of place. Luckily, there were no adverse effects on the patient. There clips were released. They used another chalanger. There was no need to re-operate. There was no serious damage. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2017-05219 |
| MDR Report Key | 6898257 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2018-01-04 |
| Device Manufacturer Date | 2015-08-31 |
| Date Added to Maude | 2017-09-27 |
| 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 | 2017-09-27 |
| Returned To Mfg | 2018-01-03 |
| Catalog Number | EL314 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-09-27 |