MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R37, 15X100 KII OPT ZTHR 6/BX; GCJ

Model Number	C0R37
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2017
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: gastric sleeve.Event description: dr.(b)(6) reported that the sleeve of the trocar is lacerated when inserting it into the patient.He had the impression that the sleeve "bent".Trocar was replaced by another.The patient was not affected.Additional info received from rep via email on 10aug2017: according to the user, the sleeve was frayed and/or torn at the lower edge.Type of intervention: n/a patient status: according to dr.(b)(6), patient was not affected.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a misshapen cannula tip.A small fracture was also observed at the tip.Based on the condition of the returned unit, it is likely that the fracture was caused by an instrument that was used during the procedure.For the misshapen cannula tip, it is likely that the cannula tip was exposed to heat.The probability and criticality of harm resulting from these failures have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.
Event or Problem Description
Additional information received from sales representative via email on 7sep2017: the cannula was fractured during the insertion.

• Brand Name: C0R37, 15X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6836619
• Report Number: 2027111-2017-01959
• Device Sequence Number: 16159378
• Product Code: GCJ
• UDI-Device Identifier: 00607915116422
• UDI-Public: (01)00607915116422(17)200125(30)01(10)1288484
• Combination Product (Y/N): N
• PMA/510(K) Number: K060096
• 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): 10/19/2017

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: 01/25/2020
• Device Model Number: C0R37
• Device Catalogue Number: 101414401
• Device Lot Number: 1288484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1