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	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
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 the investigation.
Event or Problem Description
Procedure performed: oesophagus resection.Event description: [translation]: today, during the oesophagus resection, we saw that our port had been broken.We thought this was quite dangerous.Fortunately, no plastic had broken off, but the plastic had bent.Additional information received by email from applied medical representative on (b)(6) 2022: patient status: is ok.The trocar was inserted between the thoracal bone.There was no difficulty during insertion.The trocar was not used with a robot, laparoscopic.Instruments inside of the cannula at the time of the incident: [name] grasper, needle holder.Patient status: no patient injury has been reported.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula tip.Based on the condition of the returned unit, it is possible that the cannula tip fractured due to instrumentation coming in contact with the tip during the procedure.It is also possible that the cannula was more susceptible to breakage.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: oesophagus resection.Event description: [translation]: today, during the oesophagus resection, we saw that our port had been broken.We thought this was quite dangerous.Fortunately, no plastic had broken off, but the plastic had bent.Additional information received by email from applied medical representative on 10may22: patient status: is ok.The trocar was inserted between the thoracal bone; there was no difficulty during insertion.The trocar was not used with a robot, laparoscopic instruments inside of the cannula at the time of the incident: [name] grasper, needle holder.Patient status: no patient injury has been reported.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14432077
• Report Number: 2027111-2022-00602
• Device Sequence Number: 20449459
• Product Code: GCJ
• UDI-Device Identifier: 00607915123734
• UDI-Public: (01)00607915123734(17)250310(30)01(10)1444762
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 03/10/2025
• Device Model Number: CTS22
• Device Catalogue Number: 101472328
• Device Lot Number: 1444762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIGASURE MARYLAND, GRASPER, NEEDLE HOLDER.
• Patient Sex: Prefer Not To Disclose