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

Model Number	CTR71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2017
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
Procedure performed: laparoscopic duodenal switch.Event description: "dr.[name], chief of surgery at (b)(6) hospital, was towards the end of his lap duodenal switch when a ctr71, used as he normally would, broke and the bottom third of the cannula broke clean off.The patient was not harmed and the broken portion of the cannula was retrieved and is being sent with the top portion of the cannula.Both portions of cannula have been cleaned by spd and need to be sent in.This is the second incident for this surgeon with the same product and lot number." type of intervention: no patient illness or injury.The cannula was retrieved and is being sent with the top portion of the cannula.Patient status: "no complications".
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be confirmed.In the absence of the subject device, it is difficult to determine the root cause of the event.However, based on the description of the event, it is likely that the 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 recently implemented process enhancements intended to further minimize the potential for this type of incident to occur.

• 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: 6775925
• Report Number: 2027111-2017-01916
• Device Sequence Number: 771830
• 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: K060096
• 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): 09/22/2017

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: CTR71
• Device Catalogue Number: 101470675
• Device Lot Number: 1288495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/22/2017
• Patient Sequence Number: 1