MAUDE Adverse Event Report: AMR CTB03, 5X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB03
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is to follow up with medwatch# (b)(4).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
From medwatch report: "laproscopic total hysterectomy - "blade didn't retract during surgery.No patient harm.".
Additional Manufacturer Narrative
This report was mistakenly generated.Applied medical previously submitted a report for this event which was filed under 2027111-2016-00433 (applied medical (b)(4)) on december 7, 2016.This supplemental report is to confirm that 2027111-2016-00492 (applied medical (b)(4)) was erroneously submitted.Please refer to the content within 2027111-2016-00433 (applied medical (b)(4)) for the final report.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5774018
• Report Number: 2027111-2016-00492
• Device Sequence Number: 16682
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)190216(30)01(10)1265463
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• 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): 03/01/2017

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: 02/16/2019
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1265463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/06/2016
• Supplement Report FDA Received Date: 03/01/2017
• Patient Sequence Number: 1