MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-24 for ENDO CLIP II 176657 manufactured by Davis & Geck Caribe Ltd.
[185506333]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185506354]
According to the reporter, during a laparoscopic cholecystectomy, during ligation of the cystic artery, the device was able to fire properly the first 3 clips then it produced open or malformed clips. The surgeon tried to place more clips but they turn out to be malformed and some came out fully open. The surgeon was able to control the situation by placing more clips from a new device and removed all misplaced clips from within the abdominal cavity. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612501-2020-00509 |
| MDR Report Key | 9873803 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-11-18 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | DAVIS & GECK CARIBE LTD |
| Manufacturer Street | ZONA FRANCA DE SAN ISIDRO |
| Manufacturer City | SANTO DOMINGO 18750 |
| Manufacturer Country | DO |
| Manufacturer Postal Code | 18750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO CLIP II |
| Generic Name | CLIP, IMPLANTABLE |
| Product Code | FZP |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-13 |
| Model Number | 176657 |
| Catalog Number | 176657 |
| Lot Number | J9L2334NY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVIS & GECK CARIBE LTD |
| Manufacturer Address | ZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 18750 DO 18750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |