SITUATE
Received Jul 6, 2026 · Event occurred Jun 8, 2026
Report 1717344-2026-00914 · MDR key 25728017
Device
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D10 CONCOMITANT PRODUCTS: UNK - SIBO, UNKNOWN SURGICAL INNOVATIONS BO PRODUCT (SERIAL #: UNKNOWN). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT, DURING SERVICING BY THE FACILITY, THE DEVICE DETECTED BUT NOTHING WAS THERE. THE CUSTOMER STATED THE DEVICE NEVER WORKED. THERE WAS NO PATIENT INVOLVEMENT.