MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-28 for LIGACLIP*ENDO MED/LG APPLIER EL314 manufactured by Ethicon Endo-surgery, Llc..
[101536534]
(b)(4). Batch # na. 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. Additional information was requested and the following was obtained: was there any patient consequence? No. Did clips fall off of vessel after applied? Clips fall of when physician removed the clip applier. Were clips that were applied to vessel malformed? Vessel wasn`t malformed. How was the procedure completed? Physician used another one device the same type. According to physician they using clips from other manufacturer not (b)(4) company.
Patient Sequence No: 1, Text Type: N, H10
[101536535]
Physician reported that clip applier keep clips incorrectly. Moreover even if clips has been implemented often situation is when clips can be removed from tissue without any additional force.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2018-08257 |
| MDR Report Key | 7303141 |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-03-05 |
| Device Manufacturer Date | 2014-08-31 |
| Date Added to Maude | 2018-02-28 |
| 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 | 2018-02-28 |
| Returned To Mfg | 2018-03-05 |
| 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 | 2018-02-28 |