MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-11-14 for ROTICULATOR ENDO DISSECT 5MM INSTRUMENT 174213 manufactured by Ballymoney - Uss.
[2496964]
Procedure type: laparoscopic choledocholithotomy. According to the reporter: the tip of the device was angled to left side and used for 15 minutes. To re-grasp the tissue, the surgeon checked the device's shaft and found the outside of shaft and tip of the shaft cover was split open. Another device was opened and used to complete the procedure. No bleeding occurred. No tissue damage occurred. Nothing fell into the patient cavity. Operative time was not extended more than 30 minutes. The patient is under observation.
Patient Sequence No: 1, Text Type: D, B5
[9572301]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000141-2011-00002 |
| MDR Report Key | 2382043 |
| Report Source | 01,05,06 |
| Date Received | 2011-11-14 |
| Date of Report | 2011-11-07 |
| Date of Event | 2011-11-07 |
| Date Mfgr Received | 2011-11-07 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-07-13 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 60 MIDDLETOWN AVE. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034926273 |
| Manufacturer G1 | BALLYMONEY - USS |
| Manufacturer Street | 20 GARRYDUFF ROAD BALLYMONEY CO. |
| Manufacturer City | ANTRIM BT53 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | BT53 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTICULATOR ENDO DISSECT 5MM INSTRUMENT |
| Generic Name | SINGLE USE LAPAROSCOIC HAND INSTRU |
| Product Code | GDI |
| Date Received | 2011-11-14 |
| Catalog Number | 174213 |
| Lot Number | P1A1179 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BALLYMONEY - USS |
| Manufacturer Address | 20 GARRYDUFF ROAD ANTRIM BT537A EI BT53 7A |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-14 |