MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-10 for LIGACLIP*MCA SMALL APPLIER MCS20 manufactured by Ethicon Endo-surgery, Llc..
[188416816]
(b)(4). Batch # unk. A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified. 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.
Patient Sequence No: 1, Text Type: N, H10
[188416817]
It was reported that during an unknown procedure, the customer reports that the clips didn't work well. The clamp was changed many times. The clamp didn't recharge every time and the clips didn't adhere on the tissues. Another device was used. There was no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005075853-2020-00918 |
| MDR Report Key | 9690836 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-10 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-08-06 |
| Date Added to Maude | 2020-02-10 |
| 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 | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Country | * |
| Manufacturer Postal | 00969 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON ENDO-SURGERY, LLC. |
| Manufacturer Street | 475 CALLE C |
| Manufacturer City | GUAYNABO 00969 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00969 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGACLIP*MCA SMALL APPLIER |
| Generic Name | CLIP, IMPLANTABLE |
| Product Code | GDO |
| Date Received | 2020-02-10 |
| Returned To Mfg | 2020-03-12 |
| Model Number | MCS20 |
| Catalog Number | MCS20 |
| Lot Number | T40P8N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-10 |