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 2020-01-17 for 0 ENDOLOOP LIG W/PDS II EZ10G manufactured by Ethicon Inc..
[180874504]
(b)(4). 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
[180874505]
It was reported that the patient underwent an unknown procedure on unknown date and suture was used. The suture was broken when the surgeon broke off the tip of the canula at the break point. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-00456 |
| MDR Report Key | 9601286 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-25 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-01-17 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA KM 154 |
| Manufacturer City | SAO PAOLO 12240-908 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240-908 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 0 ENDOLOOP LIG W/PDS II |
| Generic Name | CANNULA, SURGICAL, GENERAL AND PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2020-01-17 |
| Returned To Mfg | 2020-01-22 |
| Catalog Number | EZ10G |
| 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 INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |