n.a. 28160ZJRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551097199), received between Oct 16, 2020 and Oct 1, 2022 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT 28160ZJ - BIOPSY FORCEPS, 1 MM, 30 CM. THE DEVICE BROKE DURING SURGERY. ACCORDING TO THE COMPLAINT DESCRIPTION, ONE OF THE JAWS OF THE BIOPSY FORCEPS BROKE DURING VENTRICULOSTOMY IN THE CONTEXT OF THE MANAGEMENT OF A COLLOID CYST RESPONSIBLE FOR HYDROCEPHALUS. BROKEN JAW PIECE NOT FOUND. AT THIS STAGE, NO COMPLICATIONS FOR THE PATIENT. NO CLINICAL CONSEQUENCES. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523593 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PER THE CUSTOMER, ALLEGEDLY DURING A ENDOSCOPIC VENTRICULOSCOPY PROCEDURE THE BUTTERFLY HINGE OF THE GRASPER BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AND PER THE DOCTOR THE FOLLOW UP IMAGING DID NOT SHOW ANY RETAINED OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10690078 ↗