MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-24 for ESOPHYX 2 LINK KIT R2005 manufactured by Endogastric Solutions.
[48411754]
During transoral incisionless fundoplication, the esophyx 2 link kit ((b)(4)) malfunctioned. There was a plastic piece protruding from the side of the scope that prevented movement without possible damage to the esophagus. After multiple attempts, the plastic piece was withdrawn up into the scope. No patient harm. The rep took the device back with her. Diagnosis or reason for use: gerd without esophagitis. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063086 |
| MDR Report Key | 5754524 |
| Date Received | 2016-06-24 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-04-20 |
| Date Added to Maude | 2016-06-28 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | ESOPHYX 2 LINK KIT |
| Generic Name | ESOPHYX 2 LINK KIT |
| Product Code | ODE |
| Date Received | 2016-06-24 |
| Model Number | R2005 |
| Lot Number | R2005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENDOGASTRIC SOLUTIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-24 |