MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS22, 12X100 KII SLEEVE ZTHR 12/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTS22
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
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 pleurodesis.Event description: rep was not present for the case.The surgeon is a newly practicing surgeon.The surgeon placed the trocar between the rib cage and diaphragm.While looking around with the scope he noticed a broken fragment from the tip of the cannula.The case was converted to a open procedure to retrieve the plastic piece in the patient.The patient status is fine.The trocar is available to be returned.Intervention: converted to open to retrieve the plastic piece of the trocar.Patient status: patient is fine.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photographs of the event unit were provided, which confirmed the complainant's experience of a fractured cannula.In the absence of the event unit, it is difficult to determine the exact root cause of the event.However, based on the photographs provided by the complainant and the description of the event, it is likely that the location of the trocar placement caused excessive forces to be exerted on the cannula during the procedure.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 pleurodesis event description: rep was not present for the case.The surgeon is a newly practicing surgeon.The surgeon placed the trocar between the rib cage and diaphragm.While looking around with the scope he noticed a broken fragment from the tip of the cannula.The case was converted to a open procedure to retrieve the plastic piece in the patient.The patient status is fine.The trocar is available to be returned.Intervention: converted to open to retrieve the plastic piece of the trocar patient status: patient is fine.

• Brand Name: CTS22, 12X100 KII SLEEVE ZTHR 12/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: 9866461
• Report Number: 2027111-2020-00433
• Device Sequence Number: 3268128
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)221113(30)01(10)1374795
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 05/26/2020

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: 11/13/2022
• Device Model Number: CTS22
• Device Catalogue Number: 101244801
• Device Lot Number: 1374795
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE; SCOPE