MAUDE Adverse Event Report: HALYARD HEALTH MIC-KEY* G-18 LAPAROSCOPIC INTRODUCER KIT; DIGESTHEALTH ENTERAL FEED PERC PLACEMENT

Model Number	10237
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample was not available at the time this report was filed.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 03may2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
Event or Problem Description
It was initially reported that 3 of 4 t-fastener sutures broke about 1cm below locking bolster.The balloon retained internal gastronomy-tube bumper and was found to be outside the stomach, in the abdomen.The patient returned to the operating room for an open laparotomy.The physician alleged the patients stomach was not insufflated for the procedure and most likely led to complications.Additional information was received on 12-apr-2017 that states, the procedure was performed friday, (b)(6) 2017.On saturday or sunday (exact date unknown) the t-fasteners broke and the patient had a cat scan.The g-tube was found to be in the peritoneal cavity.The feeding tube was alleged not to be used.The patient was taken to the operating room for a laparotomy to have the tube removed.The feeding tube was completely intact and there were no issues with the feeding tube itself.The surgeon did not inflate the stomach during procedure/placement of t-fasteners.The patient is in stable condition.No additional information was provided.

• Common Device Name: DIGESTHEALTH ENTERAL FEED PERC PLACEMENT
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6545446
• Report Number: 9611594-2017-00071
• Device Sequence Number: 10787294
• Product Code: KGC
• UDI-Device Identifier: 10680651102376
• UDI-Public: 10680651102376
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K080253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2017

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: Physician
• Device Model Number: 10237
• Device Catalogue Number: 991010237
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2017
• Initial Report FDA Received Date: 05/04/2017
• Patient Sequence Number: 1
• Patient Age: 74 YR