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	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: subtotal hysterectomy, bilateral salpingectomies.Event description: "surgeon had placed uterus in the alexis ces bag and had pulled bag to the outside of the abdomen.After pulling white ring of alexis ces, had checked to see the location of the specimen before rolling the ring of the alexis ces and had noticed that specimen was not in bag.Had put the scope into the abdomen, had noticed that specimen had fallen out of the bag.When pulled the alexis ces out from the abdomen, there was a hole at the bottom of the bag." additional information received on march 26, 2018: "i spoke to the tm who attended the case.She said that the scrub nurse folded the alexis ces and did not notice the hole/tear.The bag was not specifically inspected for tears.The specimen was measure 2 weeks prior to the case as 12 x 11 x 8cm.After the incident, the specimen was able to be placed into a gtb14." type of intervention: unk.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned for evaluation.Visual inspection confirmed the complainants experience of a hole in the bottom of the bag.Based on the condition of the returned unit, the reported event was caused by a missing film to film seal.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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.

• 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: 7429789
• Report Number: 2027111-2018-00149
• Device Sequence Number: 16635074
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)200316(30)01(10)1296491
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 06/21/2018

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: 03/16/2020
• Device Model Number: GTK17
• Device Catalogue Number: 700314020
• Device Lot Number: 1296491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 06/21/2018
• Patient Sequence Number: 1