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
The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Lap total hysterectomy - "the blade was exposed as normal as it passed through tissue but would not retract once through." patient status - "fine.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Engineering tested the unit to evaluate if the shield would successfully cover the blade after actuation, and the shield performed as intended after actuation.The root cause could not be determined as engineering was not able to replicate the customer's experience, and the unit performed according to specification.During the manufacturing process, all bladed obturators are thoroughly inspected for functionality and performance prior to packaging.Applied medical continuously seeks to improve the form, function and ease of use of its products.Applied medical has recently implemented process enhancements intended to minimize the potential for this type of event to occur.This lot was built prior to the implementation of these enhancements.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.
Additional Manufacturer Narrative
This report is to follow up with (b)(4).
Event or Problem Description
Medwatch report description of event: "blade didn't retract during surgery.No patient harm.What was the original intended procedure? laparoscopic total hysterectomy.Device usage problem: device malfunction - that is, the device did not do what it-was supposed to do".

• 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: 5709281
• Report Number: 2027111-2016-00433
• Device Sequence Number: 208075
• 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,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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/09/2016
• Supplement Report FDA Received Date: 12/07/2016; 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR