MAUDE Adverse Event Report: ECOLAB/MICROTEK MEDICAL INC. MICROTEK; CAMERA DRAPE

Model Number	3501
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a foreign body, presumed to be tape from the camera drape, was retained in the patient.Intervention was required to remove the retained foreign body from the patient.No patient injury or infection resulting from the retained foreign body was reported.
Event or Problem Description
It was reported that a foreign body, presumed to be tape from the camera drape, was retained in the patient.Intervention was required to remove the retained foreign body from the patient.No patient injury or infection resulting from the retained foreign body was reported.

• Brand Name: MICROTEK
• Common Device Name: CAMERA 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: 15583892
• Report Number: 8043817-2022-00028
• Device Sequence Number: 5979239
• Product Code: PUI
• UDI-Device Identifier: 00748426007752
• UDI-Public: 748426007752
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 3501
• Device Catalogue Number: N/A
• Device Lot Number: D213161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown