MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTR71
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
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: "lap sleeve gastrectomy".Event description: "patient weight could have been a factor, as we were doing a bariatric procedure.Trocar snapped in half while dr.[name]" "patient is recovering from surgery with no ill-effects resulting from the incident." no materials were left in the patient.Product is available for return.Additional information received via email on 07may2021 from applied medical account manager: "the trocar snapped upon entry." "the cannula snapped in half (splintered) at about the middle.It was a ctr71 (150mm).Part of the cannula was still inside of the patients abdominal wall and was difficult to retrieve.A new trocar was inserted and the case continued with no addition issues." intervention: the trocar was removed from the patient.A new trocar was inserted to complete the case.Patient status: no patient injury, "patient is recovering from surgery with no ill-effects resulting from the incident.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.The wall thickness of the cannula shaft was uneven and did not meet specifications.Based on the condition of the returned unit and the description of the event, it is likely that the cannula fracture was caused by the uneven cannula shaft wall thickness, which occurred during the injection molding process of the cannula.
Event or Problem Description
Procedure performed: "lap sleeve gastrectomy" event description: "patient weight could have been a factor, as we were doing a bariatric procedure.Trocar snapped in half while dr.[name]" "patient is recovering from surgery with no ill-effects resulting from the incident." no materials were left in the patient.Product is available for return.Additional information received via email on 07may2021 from applied medical account manager: "the trocar snapped upon entry." "the cannula snapped in half (splintered) at about the middle.It was a ctr71 (150mm).Part of the cannula was still inside of the patients abdominal wall and was difficult to retrieve.A new trocar was inserted and the case continued with no addition issues." intervention: the trocar was removed from the patient.A new trocar was inserted to complete the case.Patient status: no patient injury, "patient is recovering from surgery with no ill-effects resulting from the incident.".

• Brand Name: CTR71, KII 12X150 Z-THR OPT SEP SYS 6/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: 11814367
• Report Number: 2027111-2021-00489
• Device Sequence Number: 3747825
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)240211(30)01(10)1406386
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 02/11/2024
• Device Model Number: CTR71
• Device Catalogue Number: 101470675
• Device Lot Number: 1406386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1