SharkCore DSL-19-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00855208005131), received between Jun 25, 2018 and Sep 3, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF THE STUDY PERFORMED, FROM OCTOBER, 2018 TO SEPTEMBER 2019. TWO OF THE PATIENTS FORM THE SAME STUDY HAD A BIOPSY USING THE COMPETITORS AND COMPANY'S DEVICE. BOTH PATIENTS REPORTED AN ABDOMINAL PAIN AFTER THE OPERATION AND HAD A CT-SCAN, WHICH SHOWED NO ABNORMAL FINDING. THE PATIENTS STAYED OVERNIGHT FOR OBSERVATION AND WERE DISCHARGED THE NEXT MORNING AFTER THEIR PAIN WAS CONTROLLED BY MEDICATION.

  Patient problems: Abdominal Pain; Radiation Exposure, Unintended

  MAUDE report 10488532 ↗
• InjuryAug 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED (MAY 2020), POST ENDOSCOPIC ULTRASOUND-GUIDED FINE NEEDLE BIOPSY, OUT OF THE 71 PATIENTS, THERE WERE 4 CASES OF ABDOMINAL PAIN WITH ONE PATIENT SEEN IN THE EMERGENCY DEPARTMENT AND WAS DISCHARGED WITH A 2-DAY NARCOTIC PRESCRIPTION, AND THE OTHER THREE WAS MANAGED WITH OVER THE COUNTER MEDICATIONS WITH NO HOSPITAL VISIT. ARTICLE: MUNISH ASHAT, MD, 2020, 25 MAY

  Patient problems: Abdominal Pain

  MAUDE report 10471236 ↗
• InjuryMar 11, 2019Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, THE PATIENT HAD A STOMACH PERFORATION DURING LIVER BIOPSY, ATTEMPTED TO REACH THE RIGHT LOBE AND ONCE PERFORATED, THE AIR ENTERED INTO THE STOMACH. THERE WERE 3 PASSES TARGETING LIVER PARENCHYMA AS WELL AS THE LESION. THE PATIENT EXPERIENCED MILD PAIN POST PROCEDURE AND INCREASED PAIN THE FOLLOWING DAY. A COMPUTED TOMOGRAPHY (CT) SCAN ABDOMEN PERFORMED SHOWED A SUBSTANTIAL AMOUNT OF FREE AIR/PNEUMOPERITONEUM. THE PATIENT WAS PUT ON ANTIBIOTICS AND AFTER 7 DAYS COURSE OF ANTIBIOTIC, THE PATIENT STILL HAD A FEVER. ANOTHER CT SCAN WAS PERFORMED AS AN OUTPATIENT WHICH APPEARED TO HAVE ATELECTASIS/POSSIBLE PNEUMONIA IN LUNG BASE AND THE PATIENT WAS ADMITTED FOR ABOUT A DAY AND ANOTHER ANTIBIOTIC WAS STARTED. PATIENT WAS DISCHARGED APPROXIMATELY 1 DAY AFTER ADMISSION. THE PHYSICIAN ALSO NOTED THAT AT THE END OF THE PROCEDURE, THERE WAS SOME DIFFICULTY OR RESISTANCE WITH THE NEEDLE REMOVAL AND HAD THE DIFFICULTY WITH GLIDING. THE PHYSICIAN STATED THAT THE NEEDLE DID NOT BEND. THERE WAS NO INJURY OR HARM TO THE PHYSICIAN.

  Patient problems: Fever; Hepatitis; Internal Organ Perforation; Pain; Pneumonia; Radiation Exposure, Unintended

  MAUDE report 8410041 ↗
• MalfunctionJun 25, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ACCORDING TO THE REPORTER, DURING THE ENDOSCOPIC ULTRASOUND OF THE LIVER, THE PHYSICIAN DID ANOTHER PASS FOR LIVER BIOPSY AND THE ORANGE HUB BROKE OFF OF THE NEEDLE. IT BROKE OFF WHERE THE ORANGE TIP WAS. THE CUSTOMER DID NOT KEEP THE NEEDLE AS THEY CANNOT HOLD ON TO "SHARPS." THE ITEM WAS A SHARP AND WAS DISPOSED OF IN A SHARPS CONTAINER FOR SAFETY. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA, NO MEDICAL INTERVENTION WAS DONE, AND THE PROCEDURE WAS ABORTED, BUT NO REPEAT PROCEDURE WAS PERFORMED. THERE WAS NO PATIENT AND USER INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635781 ↗