MAUDE Adverse Event Report: MITG - KENMEX KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	762000
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Submit date: (b)(6) 2017.Mansfield product monitoring is attempting to gather additional information of the reported event.To date, no clarification has been received.If additional pertinent information becomes available, the report will be updated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparotomy on (b)(6) 2017 for drainage of hemoperitene, gastrorrhaphy, gastrostomy, the device guide broke the handle of the wire during extraction.There was an extension of hospitalization due to removal of guide wire via surgery.The patient status was unknown.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis however, a corrective and preventative action was created to address the reported failure.The production personnel were notified of the condition.A quality alert was performed in order to verify the machine complete cycle.The procedure was updated to improve the method used by the machine for assembly.A sensor was implemented to detect and avoid cycle interruption.Additional specific job activities were added for the machine used for assembly and the slide lot plate was replaced for cycle activation.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): MITG - KENMEX; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• MDR Report Key: 6980042
• Report Number: 9612030-2017-05220
• Device Sequence Number: 18957002
• Product Code: KNT
• UDI-Device Identifier: 30884521020164
• UDI-Public: 30884521020164
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 762000
• Device Catalogue Number: 762000
• Device Lot Number: 613182364X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2017
• Supplement Date Received by Manufacturer: 10/07/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 02/06/2018
• 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: Hospitalization; Required Intervention