MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. STRYKER, MAKO; ROBOTIC DRAPE

Model Number	111320
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there were problems with two robotic drapes from the same lot.One drape had a hole.The second drape folding was not done as usual and the base array fell off during unpackaging.Both problems were noticed before the medical procedure and there was no impact to the patient or patient injury.

• Brand Name: STRYKER, MAKO
• Common Device Name: ROBOTIC DRAPE
• Manufacturer (Section D): ECOLAB/MICROTEK MEDICAL INC.; 1 ecolab pl; st. paul MN 55102
• Manufacturer (Section G): MICROTEK DOMINICANA, S.A.- LA ROMANA; zona franca no. 2; la romana, la romana ; DR
• Manufacturer Contact: emily scott ; 1 ecolab pl; st. paul, MN 55102
• MDR Report Key: 14453396
• Report Number: 8043817-2022-00008
• Device Sequence Number: 6354697
• Product Code: PUI
• UDI-Device Identifier: 50748426117586
• UDI-Public: 50748426117586
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2026
• Device Model Number: 111320
• Device Catalogue Number: N/A
• Device Lot Number: D210071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown