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

Model Number	GTK17
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2016
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Robotic total laparoscopic hysterectomy - "dr.(b)(6) was dissatisfied because the bag ripped when trying to extracoprealize the specimen.Said the bag material could use improvements.Doctor did manually morcellate before removal.Bag was not attempted to be removed before all tissue was removed.The type of tissue was the uterus.Dr.(b)(6) saw there was a tear near the alexis ring, guard was not used.The rip was noticed at two points during the procedure was when he was trying to place the specimen in the bag (said the instrumentation of placing specimen through alexis ring caused a small tear).After specimen was placed in the bag he was pulling on the alexis ring to bring the specimen closer to surface and he had a second tear take place.Not sure of what instruments were used to place the bag in the patient or to place the specimen in the bag." patient status - "no patient injury".
Additional Manufacturer Narrative
The event unit was not returned for evaluation.Based on the description of the complainant's experience, the rip/tear was likely caused by the bag coming into contact with instrumentation during specimen placement.The instructions for use (ifu) caution the user that, "the specimen containment bag is not intended to come into contact with sharp or traumatic instrumentation and cutting devices." applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of its products.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, 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): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5897122
• Report Number: 2027111-2016-00596
• Device Sequence Number: 18964827
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)190324(30)01(10)1271487
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/22/2017

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: Other
• Device Expiration Date: 03/24/2019
• Device Model Number: GTK17
• Device Catalogue Number: 700314020
• Device Lot Number: 1271487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2016
• Supplement Report FDA Received Date: 02/22/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other