Porges Coloplast DOR424Recalls & reported problems
Coloplast A/S · DORMIA® Stone extractor 3 CH/FR with an "extractible basket" · Class 2
All models of Porges Coloplast (79)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03600040227497), received between Mar 9, 2017 and Mar 9, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Code Available1
- Tissue Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2017Break
ACCORDING TO THE AVAILABLE INFORMATION, FOR THE SURGERY A PENTAX ENDOSCOPE AND A DORMIA WERE USED. THEY CAPTURED THE STONE, BUT IT WAS NOT ABLE TO PASS THE PAPILLA. DUE TO THIS THEY CONTINUED WITH THE STONE FRAGMENT DEVICE (THE STONE FRAGMENT DEVICE IS A MECHANICAL LITHOTRIPTOR). DURING COMPRESSION, THE WIRE OF THE BASKET BROKE. NEVERTHELESS, THE FRAGMENTED STONE COULD BE REMOVED WITH THE BROKEN BASKET AND THE ENDOSCOPE. THIS RESULTED IN A LONGITUDINAL CRACK OF THE DUODENAL WALL WITH STRONG BLEEDING. HEMOSTASIS WAS NOT POSSIBLE. DUE TO THIS 2ND SURGERY (LAPAROTOMY) AT THE SAME DAY. AFTER 2 MORE RE-LAPAROTOMIES AND CLOSURE OF FISTULA THE PATIENT IMPROVED. HE WAS RELEASED FROM THE HOSPITAL TO OUTPATIENT TREATMENT - SUBJECTIVELY HE FELT GOOD. IT IS NOT CLEAR WHICH LOT OF THE DORMIA WAS USED, LOTS 10050286 AND 10070002. BOTH LOTS EXPIRED IN 2015. DOR424 IS NOT INDICATED FOR BILIARY EXTRACTION, AND FOR USE WITH ANY LITHOTRIPTOR. DEVICE WAS PROBABLY EXPIRED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available; Tissue Damage
MAUDE report 6390959 ↗
Other DISLODGER, STONE, BASKET, URETERAL, METAL devices
- Zero Tip M0063901050Boston Scientific Corporation · DISLODGER, STONE, BASKET, URETERAL, METAL287 reports
- NCircle G18778Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL226 reports
- NCircle G46206Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL197 reports
- NCircle G17520Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL129 reports
- NGage G48297Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL96 reports
- NGage G48294Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL92 reports
- NCircle G19110Cook Incorporated · DISLODGER, STONE, BASKET, URETERAL, METAL88 reports
- Bard® SkyLite™ Tipless Nitinol Stone Basket 041900C. R. Bard, Inc. · DISLODGER, STONE, BASKET, URETERAL, METAL78 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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