Disposable Handle Polaris, Single MP05701Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04048675540120), received between Apr 15, 2025 and Apr 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Activation, Positioning or Separation Problem1
Device Fell1
Insufficient Device Problem Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 15, 2025Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Device Fell; Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Device Fell
IT WAS REPORTED THAT AFTER THE DISPOSABLE HANDLE HAD DETACH FROM ITS BLUE BASE DURING LAPAROTOMY, THE USER PROCEEDED TO WASH THE PATIENT ABDOMEN WITH DERMAL BETADINE, FOLLOWED BY SALINE SOLUTION TO AVOID INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21838265 ↗

Device details

UDI-DI	`04048675540120`
Brand	Disposable Handle Polaris, Single
Model	MP05701
Company	Drägerwerk AG & Co. KGaA
Product code	FTA · Light, Surgical, Accessories
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 18, 2024

Device type (GMDN): Medical equipment handle cover, single-use

A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.

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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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