EXCEL 60-6050-097Recalls & reported problems
Conmed Corporation · EXCEL 10ft (3.05 M) INSUFFLATION TUBING SET WITH 0.1 MICRON FILTER · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30653405038300), received between Mar 12, 2018 and Nov 27, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 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
Device problems
- Delivered as Unsterile Product2
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2018Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE DISTRIBUTOR REJECTED THE 60-6050-097, TUBING FOR DAMAGE TO PACKAGING. AFTER FURTHER ASSESSMENT AND EVALUATION A BREACH OF STERILITY WAS FOUND BY USING THE DYE LEAK TESTING THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8107318 ↗MalfunctionMar 12, 2018Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR IN (B)(6) REJECTED ONE (B)(4) INSUFFLATION TUBE DUE TO DAMAGED PACKAGING. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7331954 ↗MalfunctionMar 12, 2018Delivered as Unsterile Product; Delivered as Unsterile Product
THE DISTRIBUTOR IN (B)(6) REJECTED ONE (B)(4) INSUFFLATION TUBE DUE TO DAMAGED PACKAGING. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.
Patient problems: No Patient Involvement
MAUDE report 7331881 ↗
Other Tubing/tubing with filter, insufflation, laparoscopic devices
- n.a. 20400028Karl Storz GmbH & Co. KG · Tubing/tubing with filter, insufflation, laparoscopic5 reports
- NA 0620030301Stryker Corporation · Tubing/tubing with filter, insufflation, laparoscopic2 reports
- Valleylab SEL7010Covidien LP · Tubing/tubing with filter, insufflation, laparoscopic1 report
- EXCEL 60-6050-098Conmed Corporation · Tubing/tubing with filter, insufflation, laparoscopic1 report
- n.a. 031210-10Karl Storz GmbH & Co. KG · Tubing/tubing with filter, insufflation, laparoscopic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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