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

Model Number	33
Medical Device Problem Codes	Break (1069); Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2016
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
Laparoscopic supracervical hysterectomy - "during manual morcellation of specimen, gas was observed to be leaking through bag.Contained extraction system was inspected after morcellation was completed and two holes were observed." patient status - stable.
Additional Manufacturer Narrative
The event product was not returned for evaluation; however, an image of the unit was provided.In the absence of the subject device, it can be difficult to determine the root cause of the incident.A review of the device history records for this lot confirmed that the lot passed all manufacturing and quality inspections.Engineering also attempted to replicate the events described in the customer report using a representative unit.The root cause is likely due to the bag being punctured by a sharp instrument as determined by the type and location of the holes.The instructions for use (ifu) state, "care should be taken to avoid causing damage to the specimen containment bag during use.The specimen containment bag is not intended to come into contact with sharp or traumatic instrumentation or 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.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.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.
Event or Problem Description
Laparoscopic supracervical hysterectomy - "during manual morcellation of specimen, gas was observed to be leaking through bag.Contained extraction system was inspected after morcellation was completed and two holes were observed." patient status - stable.

• 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: 5726402
• Report Number: 2027111-2016-00425
• Device Sequence Number: 16161570
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)180825(30)01(10)1261154
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: 33
• 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): 03/07/2017

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: Health Professional
• Device Expiration Date: 08/25/2018
• Device Model Number: 33
• Device Catalogue Number: 33
• Device Lot Number: 1261154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2016
• Supplement Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1