EXPEDIUM 299704145Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705034467245), received between Nov 8, 2023 and Nov 10, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1) PENCIL HANDLE. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18110325 ↗
• MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED. THIS REPORT IS FOR ONE (1)PENCIL HANDLE THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18099480 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1)PENCIL HANDLE. THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096884 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1)PENCIL HANDLE THIS IS REPORT 8 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096881 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED. THIS REPORT IS FOR ONE (1)PENCIL HANDLE. THIS IS REPORT 9 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096879 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, OCTOBER 18TH, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED THIS REPORT IS FOR ONE (1)PENCIL HANDLE THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4)

  Patient problems: Insufficient Information

  MAUDE report 18096878 ↗
• MalfunctionNov 8, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED ON WEDNESDAY, (B)(6) 2023, SETS WERE DROPPED OFF FOR CASES ON FRIDAY, OCTOBER 20TH. UPON RECEIPT OF THESE SETS, THERE WERE MULTIPLE INSTRUMENTS THAT WERE DUBBED UNFIT TO BE USED IN SURGERY (PART NUMBERS OF EACH INSTRUMENT HAVE BEEN INCLUDED). SPD RAN A BOROSCOPE DOWN EACH OF THE CANNULATED INSTRUMENTS (WHICH WE AS REPS DO NOT HAVE ACCESS TO AT ANY OF OUR ACCOUNTS TO CHECK THESE OURSELVES), AND FOUND MULTIPLE INSTRUMENTS THAT FELL OUTSIDE OF THEIR GUIDELINES FOR SAFE USE IN SURGERY. SUBSEQUENTLY, I HAD TO RUN TO MULTIPLE DIFFERENT HOSPITALS AROUND DENVER TO BE ABLE TO MAKE THESE SETS COMPLETE AND USABLE. THIS PUT ME OUTSIDE OF THE GUIDELINES PUT IN PLACE BY THE VA IN TERMS OF TIMELINESS ON DROPPING OFF THE TRAYS. EVENT OCCURRED DURING STERILE PROCESSING AND FIELD INSPECTION. THERE WERE PATIENT OUTCOMES OR CONSEQUENCES. ONE OF THE TWO CASES SCHEDULED HAD TO BE CANCELLED. THIS REPORT IS FOR ONE (1)PENCIL HANDLE THIS IS REPORT 6 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18096877 ↗