Zimmon G22983Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002229839), received between Sep 23, 2019 and Sep 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Material Deformation; Material Deformation

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT. INITIAL INFORMATION INDICATED THAT THE DEVICE WAS A ZSO-7-15. HOWEVER, IT'S BEEN CONFIRMED THAT THE DEVICE WAS A SPSOF-7-15. NO REPORTING PRECEDENCE IS IN PLACE FOR THE MALFUNCTION IN THIS EVENT FOR THIS PRODUCT FAMILY. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. RISK FOR THIS MALFUNCTION HAS BEEN ASSESSED AS LOW. LOW RISK OF FAILURE MODE INDICATES NO POTENTIAL FOR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF STENT KINKED/BENT. DOCTOR WANTED TO INSERT THE ZSO-7-17 IN THE CBD. SO THE NURSE PREPARED THE ZSO-7-7, BUT THE PIGTAIL SECTION WAS BENT AS SHE MOVED THE STENT SLEEVE TO THE PIGTAIL SECTION. SHE TRIED TO PASS THE GIUIDE WIRE INTO THE ZSO-7-7, IT WAS IMPOSSIBLE, SO THEY USED THE NEW ONE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9102695 ↗