MAUDE Adverse Event Report: APPLIED MEDICAL GTB17, ALEXIS CONTAINED EXTRACT SYS 5/BX; GCJ

Model Number	GTB17
Medical Device Problem Codes	Cut In Material (2454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	02/15/2016
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Total lap hysterectomy - "bag was used umbilical, shield was placed.During morcellation, the surgeon noticed damage to the bag.Unknown if caused by clamping or by a direct cut by a scalpel.Cut was several cm long, belowside the shield." type of intervention: re-operated on (b)(6) 2016.Patient status ok.Doing better (b)(6) 2016.
Additional Manufacturer Narrative
Investigation summary: the incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.  applied medical has reviewed the details surrounding the incident and related products.At this time, applied medical is unable to determine the cause of the event.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: GTB17, ALEXIS CONTAINED EXTRACT SYS 5/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5509323
• Report Number: 2027111-2016-00234
• Device Sequence Number: 10827057
• Product Code: GCJ
• UDI-Device Identifier: 00607915134280
• UDI-Public: (01)00607915134280(17)180611(30)01(10)1248368
• 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): 02/19/2016

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?: No
• Operator of Device: Other
• Device Expiration Date: 06/11/2018
• Device Model Number: GTB17
• Device Catalogue Number: 101422701
• Device Lot Number: 1248368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention