Valleylab E3773-36Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521549029), received between Jul 18, 2019 and Sep 25, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE'S INSULATION SHEATH PART OF LONG BLUE LAPAROSCOPIC HOOK WAS CRACKED FROM TOP TO BASE. OPENED A SECOND ONE AND THE SAME. OPENED A THIRD ONE AND IT WAS OK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301127 ↗
• MalfunctionSep 25, 2024Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ELECTRODE'S INSULATION SHEATH PART OF LONG BLUE LAPAROSCOPIC HOOK WAS CRACKED FROM TOP TO BASE. OPENED A SECOND ONE AND THE SAME. OPENED A THIRD ONE AND IT WAS OK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301018 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DISSECTION HOOK FRACTURED. IT WAS REPORTED THAT THIS TYPE OF DEVICE WAS FOR SINGLE USE BUT REUSED IN THE INSTITUTION. THE PIECE FELL INTO PATIENT CAVITY AND WAS FULLY RETRIEVED. NO X-RAY REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20071593 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TRANS ABDOMINAL PRE-PERITONEAL, THE ELECTRODE TIP OF THE DEVICES WERE BROKEN AND THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. WHEN A NEW PRODUCT WAS OPENED, THE ELECTRODE TIP WAS BROKEN AGAIN. THE THIRD NEW PRODUCT WAS USED WITHOUT PROBLEMS, SO THE PROCEDURE WAS PROCEEDED WITHOUT PROBLEMS. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803947 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TRANS ABDOMINAL PRE-PERITONEAL, THE ELECTRODE TIP OF THE DEVICES WERE BROKEN AND THE PART FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED. WHEN A NEW PRODUCT WAS OPENED, THE ELECTRODE TIP WAS BROKEN AGAIN. THE THIRD NEW PRODUCT WAS USED WITHOUT PROBLEMS, SO THE PROCEDURE WAS PROCEEDED WITHOUT PROBLEMS. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803917 ↗