MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX; GCJ

Model Number	3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
This cer (b)(4) will address the event device 2 of 2.Cer (b)(4) will address the event device 1 of 2.Procedure performed - robotic gastric sleeve."i need to bring to your attention that dr.[doctor's name] has had 2 different cases where the ctr71 trocar broke and pieces needed to be removed from the patient.The lot number from the trocar used in his case today is 1288495." additional information was received via telephone from the territory manager on 07-june-2017.The "dog bone" clamp was placed on the trocar and the surgeon advanced the scope and the trocar cracked in half.The break was a clean break and the surgeon retrieved approximately 1" of the broken trocar out of the patient's abdomen.The trocar was replaced and the surgery was completed without incident.Type of intervention - 1" of the broken trocar was retrieved from the patient's abdomen.Patient status - unknown.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience of a fractured cannula.The wall thickness of the cannula was measured and was found to be uneven.The likely root cause of the fracture is the uneven cannula wall thickness, which occurred during the injection molding process of the cannula.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has implemented process enhancements intended to further minimize the potential for this type of incident to occur.The event product was manufactured prior to the process enhancements.This report is to follow up medwatch # mw5070191.
Event or Problem Description
Additional information received vial mail on 22-june-2017 from medwatch #mw5070191: department of health & human services."applied kii optical 12 x 150 was used and broke in half when lens was inserted into it.Bottom half was retrieved from pt's abdomen and no injury was noted".

• Brand Name: CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6644185
• Report Number: 2027111-2017-01862
• Device Sequence Number: 16375200
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)200206(30)01(10)1288495
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 3
• 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): 07/20/2017

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: 02/06/2020
• Device Model Number: 3
• Device Catalogue Number: 3
• Device Lot Number: 1288495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1