MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR12, 5X100 KII OPT ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to be returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: according to the stock controller, the trocar broke off in the patient.Additional information received from distributor via email 17mar20: the sleeve and obturator broke.No pieces fell into the patient.Doctor pushed into the patient and broke while doing it.The trocar was cleanly broken.A new trocar was opened.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured trocar.The cannula and obturator were fractured with no cracking observed at the location of the fracture.Engineering measured the wall thickness of the cannula and obturator and found that both met specifications.Based on the condition of the returned unit and the event description, it is likely that the reported event was caused was caused by a high insertion force that was applied to the trocar during insertion.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy event description: according to the stock controller, the trocar broke off in the patient.Additional information received from distributor via email 20: the sleeve and obturator broke.No pieces fell into the patient.Doctor pushed into the patient and broke while doing it.The trocar was cleanly broken.A new trocar was opened.Patient status: no patient injury.

• Brand Name: CTR12, 5X100 KII OPT ZTHR DP 10/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9845614
• Report Number: 2027111-2020-00429
• Device Sequence Number: 755452
• Product Code: GCJ
• UDI-Device Identifier: 00607915123505
• UDI-Public: (01)00607915123505(17)220604(30)01(10)1359327
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: CTR12
• Device Catalogue Number: 101094501
• Device Lot Number: 1359327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1