MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Model Number	ML02-0106
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported following a patient endoscopy procedure, an endoscope was being precleaned with intercept detergent when the physician returned and inserted the endoscope into the patient again.The patient was exposed to the intercept detergent remaining on the endoscope being used.Medivators regulatory affairs contacted the facility to provide the intercept detergent safety data sheet and provided the (b)(4) emergency phone number.The facility reported the affected patient had experienced massive trauma prior to the procedure and therefore it would be difficult to identify the symptoms specific to the intercept detergent chemical exposure.Medivators ra followed up again with the facility two weeks later and they reported the patient was doing fine.They reported to have changed their endoscope reprocessing processes to avoid this event from happening again.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
The facility reported following a patient endoscopy procedure, an endoscope was being precleaned with intercept detergent when the physician returned and inserted the endoscope into the patient again.The patient was exposed to the intercept detergent remaining on the endoscope being used.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7351225
• Report Number: 2150060-2018-00020
• Device Sequence Number: 592161
• Product Code: MNL
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2018

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: No Information
• Device Model Number: ML02-0106
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other