MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA DISPOSABLE HANDLE POLARIS, SINGLE; LIGHT, SURGICAL, ACCESSORIES

Model Number	MP05701
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Insufficient Device Problem Information (3190); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
Event or Problem Description
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.
Additional Manufacturer Narrative
The product "disposal handle polaris" consists of three components: disk, snap ring and cover bag, which are connected to each other by a snap mechanism.The cover bag is additionally heat welded to the backside of the disk on eight different positions.The affected parts were requested for the investigation.Disk and snap ring were provided, therfore the described problem of a fallen of cover bag was confirmed.The parts were visually inspected, no deviations were found.The welding points between cover bag and disc are present and at the right number.The snap ring was tightly fitted into the disc.No residuals of the cover bag are present.No cracks in the material could be observed.The snap ring was disassembled to inspect the components for possible faults.No abnormalities could be identified.The assembly could then be reassembled without difficulty.The strength of the connection is specified and is tested during production.No deviations were found during production according to the inspection protocol of the manufacturer.It was not possible to determine the root cause.This case is handled a s a single case.Therefore, a systematic product problem can be excluded.
Event or Problem Description
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.

• Brand Name: DISPOSABLE HANDLE POLARIS, SINGLE
• Common Device Name: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 21838265
• Report Number: 9611500-2025-00195
• Device Sequence Number: 12966018
• Product Code: FTD
• UDI-Device Identifier: 04048675540120
• UDI-Public: (01)04048675540120
• Combination Product (Y/N): N
• PMA/510(K) Number: -
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MP05701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown