STEALTH® FIBRA® CLAMP INSERT A0G02Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607915114732), received between Mar 6, 2017 and Mar 6, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2017Break; Break

  PROCEDURE PERFORMED UNKNOWN - "PLEASE SEE THE ATTACHED REPORT (B)(4) WITH PICTURES. EVENT DESCRIPTION (ON (B)(6) 2016) DURING A CHECK PRIOR TO USE, A MEDICAL STAFF TRIED TO ATTACH THE INSERT TO A CLAMP MADE BY APPLIED MEDICAL. UNFORTUNATELY ONE OF THE PLASTIC BASE STOPPER TIP WAS BROKEN AND IT FAILED TO BE ATTACHED TO THE CLAMP. AT THE HOSPITAL, THE SAME EVENT (PLASTIC TIP BREAKAGE) WAS OCCURRED TWICE WITHIN THE PAST 7 DAYS BEFORE MAKING THIS REPORT. THIS EVEN DIDN'T AFFECT THE PATIENT. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." COMMENTS FROM (B)(4) - "ONE (1) UNIT OF INSERT WAS RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICE AND FOUND THAT ONE OF THE PLASTIC BASE TIP WAS BROKEN. THE PRODUCT WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382270 ↗
• MalfunctionMar 6, 2017Break; Break

  "PLEASE SEE THE REPORT (B)(4) WITH PICTURES. EVENT DESCRIPTION (ON (B)(6) 2016) DURING A CHECK PRIOR TO USE, A MEDICAL STAFF TRIED TO ATTACH THE INSERT TO A CLAMP MADE BY APPLIED MEDICAL. UNFORTUNATELY, ONE OF THE PLASTIC BASE STOPPER TIP WAS BROKEN AND IT FAILED TO BE ATTACHED TO THE CLAMP. AT THE HOSPITAL, THE SAME EVENT (PLASTIC TIP BREAKAGE) WAS OCCURRED TWICE WITHIN THE PAST 7 DAYS BEFORE MAKING THIS REPORT. THIS EVEN DIDN'T AFFECT THE PATIENT. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." COMMENTS FROM (B)(6) - "ONE (1) UNIT OF INSERT WAS RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICE AND FOUND THAT ONE OF THE PLASTIC BASE TIP WAS BROKEN. THE PRODUCT WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6382269 ↗
• MalfunctionMar 6, 2017Break; Break

  BEFORE PROCEDURE - "PLEASE SEE THE REPORT (B)(4) WITH PICTURES." EVENT DESCRIPTION: "(ON (B)(6) 2016) DURING A CHECK PRIOR TO USE, A MEDICAL STAFF TRIED TO ATTACH THE INSERT TO A CLAMP MADE BY APPLIED MEDICAL. UNFORTUNATELY ONE OF THE PLASTIC BASE STOPPER TIP WAS BROKEN AND IT FAILED TO BE ATTACHED TO CLAMP. AT THE HOSPITAL, THE SAME EVENT (PLASTIC TIP BREAKAGE) WAS OCCURRED TWICE WITHIN THE PAST 7 DAYS BEFORE MAKING THIS REPORT. THIS EVENT DIDN'T AFFECT THE PATIENT. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." COMMENTS FROM (B)(6): - "ONE (1) UNIT OF INSERT WAS RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICE AND FOUND THAT ONE OF THE PLASTIC BASE TIP WAS BROKEN. THE PRODUCT WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE." PATIENT STATUS: "NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382268 ↗