MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; IN ROOM KIT

Catalog Number	DYKM1555
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that in the middle of a colonoscopy the head of the endoscopic cleaning brush fell out of the scope while inside of the patient.Reportedly, the physician had to manually retrieve, from the patient's rectum, the detached brush head.Per report, during previous cleaning of the endoscope, the endoscopic cleaning brush head detached from the tubing and was lodged in the endoscope.The endoscope was sent to an outside facility for cleaning and maintenance and returned to the facility for use.While performing the colonoscopy the brush head fell into the patient during the procedure.The surgeon was able to remove the brush head without further incident.The patient was not under general anesthesia at the time of the incident.The procedure did not last longer than expected.There was no report of any adverse patient consequence, no effect on the patient's stability, and no additional medical intervention required as a result of the incident.The sample was returned for evaluation and the root cause was determined to be maintenance error.Due to the need for medical intervention to retrieve the separated brush head, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient was undergoing a colonoscopy and a detached brush head from an endoscopic cleaning brush fell out of the scope while inside of the patient.

• Common Device Name: IN ROOM KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7735965
• Report Number: 1417592-2018-00075
• Device Sequence Number: 14114386
• Product Code: MNL
• UDI-Device Identifier: 10889942735143
• UDI-Public: 10889942735143
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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: Health Professional
• Device Catalogue Number: DYKM1555
• Device Lot Number: GM10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 82