MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-03 for COMMON BILE DUCT EXPLORATION SET C-CDES-100 manufactured by Cook Inc.
[182930946]
Concomitant products: laparoscopic maryland grasper, olympus ureteroscope. Pma/510(k): preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[182930947]
It was reported that the roadrunner pc wire guide included in a common bile duct exploration set stripped and became damaged during use in a laparoscopic cholecystectomy with an intraoperative cholangiogram and common bile duct exploration. The wire could have become stripped upon introduction into the working channel of the ureteroscope or during manipulation with the laparoscopic grasper used in the procedure. The damage occurred upon the 4th exchange. The 1st exchange was advancing the balloon dilation catheter over the wire, the 2nd exchange was the choloedochscope over the wire, the 3rd exchange was advancing the balloon dilation catheter of the wire, and the 4th exchange was the ureteroscope over the wire. The surgeon confirmed the wire guide stripped but no pieces came off or were left inside the patient. No other adverse effects were reported for this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00529 |
| MDR Report Key | 9779787 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2020-01-28 |
| Date Added to Maude | 2020-03-03 |
| 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 | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMMON BILE DUCT EXPLORATION SET |
| Generic Name | LQR DISLODGER, STONE BILIARY |
| Product Code | LQR |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-03-02 |
| Model Number | NA |
| Catalog Number | C-CDES-100 |
| Lot Number | 10082585 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-03 |