NA 532.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982240323), received between Dec 1, 2017 and Jul 8, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Output below Specifications” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2020Premature Separation; Premature Separation

  IT WAS REPORTED FROM (B)(6) THAT THE LID DEVICE DETACHED FROM THE CASING DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10244716 ↗
• MalfunctionJan 12, 2018Output below Specifications; Output below Specifications

  THIS IS EVENT 3 OF 3 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR OF THE SMALL BATTERY DRIVE DEVICE HAD LACK OF POWER WHILE IN USE WITH TWO CASING DEVICES. THE REPORTER INDICATED THAT THEY WERE NOT SURE WHERE THE ISSUE CAME FROM. IT WAS UNKNOWN IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SPARE DEVICE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185529 ↗
• MalfunctionJan 12, 2018Output below Specifications; Output below Specifications

  THIS IS EVENT 2 OF 3 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MOTOR OF THE SMALL BATTERY DRIVE DEVICE HAD LACK OF POWER WHILE IN USE WITH TWO CASING DEVICES. THE REPORTER INDICATED THAT THEY WERE NOT SURE WHERE THE ISSUE CAME FROM. IT WAS UNKNOWN IF THERE WAS A DELAY TO THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SPARE DEVICE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185498 ↗
• MalfunctionDec 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY CASING DEVICE HAD AN UNSPECIFIED MALFUNCTION. IT WAS UNKNOWN IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7076756 ↗