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

Model Number	GTK17
Medical Device Problem Codes	Break (1069); Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the investigation.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
Myomectomy- "during use of the device the surgeon made a small incision with the surgical scissors in the alexis ces bag during specimen morcelation." type of intervention: "unknown." patient status: "unknown.".
Additional Manufacturer Narrative
Additional information requested and received.Patient status: "the patient status is okay.No cancerous cells where discovered in the specimen" investigation summary: all components of the alexis contained extraction system were returned for evaluation.Upon visual inspection, engineering noted several cut marks on the guard.Engineering performed a water fill test to identify damage of the bag and found one cut on the bottom portion of the bag.The cut was examined under a microscope and appeared to be a small v-shaped line in profile.Engineering confirmed the complainant's experience that the event device was damaged by scissors.The instructions for use (ifu) states "the specimen containment bag is not intended to come into contact with sharp or traumatic instrumentation and cutting devices." and cautions the user to "use a scalpel to manually morcellate the specimen, with care taken to not grasp or cut the bag." in accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the 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): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5788311
• Report Number: 2027111-2016-00523
• Device Sequence Number: 13722269
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)190203(30)01(10)1268091
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142427
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2016

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: 1268091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1