MAUDE Adverse Event Report: AMR GTK17, ALEXIS CES W 12X100 KII BAL BLNT; GCJ

Model Number	GTK17
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Robot hysterectomy bso - "after placing the bag through the 1.5mm incision and placing the uterus in the bag, dr.(b)(6) pulled the bag up to skin level to roll it down and morcellate the uterus.When she put the blade guard in (the new one that locks into place), she was still having trouble with the blade guard slipping out of the incision.The patient's dr.(b)(6) specializes in are obese patients (300-400 lbs) with fibroid-filled uteri.This patient was over (b)(6) and had many fibroids on her uterus.When dr.(b)(6) brought the uterus to the incision surface to morcellate, the blade guard was not able to accommodate the patient's thick abdominal wall, even when the placed an alexis retractor in the incision to compress the abdominal wall.While trying to break up the fibroids, she ended up cutting through the bag a few times where the blade guard protected." patient status: "stable.".
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.This is consistent with the initial intake of the complaint which detailed that the product would not be returned.From the description of the incident, engineering was able to determine a possible root cause.During the manufacturing process, the alexis contained extraction system is thoroughly inspected for damage.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.The root cause is most likely due to the instructions for use (ifu) not being followed.The ifu specifies an umbilical incision site which was not utilized in this incident.Furthermore, the guard component was not in place throughout manual morcellation.Applied medical continuously seeks to improve the form, function and ease of use of its products and will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: GTK17, ALEXIS CES W 12X100 KII BAL BLNT
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5704860
• Report Number: 2027111-2016-00428
• Device Sequence Number: 16155608
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)190203(30)01(10)1267420
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2016

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: Other
• Device Expiration Date: 02/03/2019
• Device Model Number: GTK17
• Device Catalogue Number: 700314020
• Device Lot Number: 1267420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 11/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 181