MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GTB17, ALEXIS CONTAINED EXTRACT SYS 10BX; GCJ

Model Number	GTB17
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2016
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 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
Procedure performed unknown - "uterus was placed in alexis ces bag and the bag ring was extracted through the umbilical incision.Incision was enlarged with scissor and cold knife with the bag in place.Bag showed three holes upon testing with water post procedure.Morcellation was under direct visualization.Guard showed small cut on the outer rim post procedure." patient status - unknown.
Additional Manufacturer Narrative
Correction: product information, updated to reflect component level, not kit level.Investigation summary: the event unit, including the specimen bag, guard, tether cord and tag, were returned for evaluation.Engineering filled the bag with water to identify the location of the damage.Five cuts were found at the bottom of the bag, and appeared to be in a straight line.Noticeable damage was noted at two locations on the cutting guard.It is likely that the cuts on the bag were caused by a scalpel during manual morcellation.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" use a scalpel to manually morcellate the specimen, with care taken to not grasp or cut the bag." the cuts to the guard are likely due to interaction with a scalpel.The bag was not damaged under the area covered by the guard.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.

• Brand Name: GTB17, ALEXIS CONTAINED EXTRACT SYS 10BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6106418
• Report Number: 2027111-2016-00758
• Device Sequence Number: 16356876
• Product Code: GCJ
• UDI-Device Identifier: 20607915134826
• UDI-Public: (01)20607915134826(17)190324(30)01(10)1271231
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/16/2017

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: Other
• Device Expiration Date: 04/14/2019
• Device Model Number: GTB17
• Device Catalogue Number: 101422701
• Device Lot Number: 1268102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1