MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180V manufactured by Olympus Medical Systems Corp..
[184082081]
The patient was undergoing endoscopic retrograde cholangiopancreatography when the duodenoscope was in pt at the ampulla, about to cannulate the bile duct. No interventions had been performed yet with the duodenoscope. The sphincterotome was passed through the scope and the md felt resistance was met while trying to push the sphincterotome through the channel. Then a portion of an old stent was noted on the scope screen. The scope was immediately removed from the patient and it was noted that an old stent from some previous pt/procedure was stuck in the scope and never came out during scope processing. The scope was sequestered and given to scope processing, evening shift supervisor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9852970 |
| MDR Report Key | 9852970 |
| Date Received | 2020-03-19 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-07 |
| Report Date | 2020-03-10 |
| Date Reported to FDA | 2020-03-10 |
| Date Reported to Mfgr | 2020-03-19 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVIS EXERA II DUODENOVIDEOSCOPE |
| Generic Name | DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID |
| Product Code | FDT |
| Date Received | 2020-03-19 |
| Model Number | TJF-Q180V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |