MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB33, 11X100 KII SH BLD ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB33
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Procedure performed: coelioscopie / laparoscopy.Event description: [translation] when the first single-use retractable-blade trocar was inserted, the blade appeared to have come out of the trocar sheath on entering the peritoneum, resulting in a wound on the small intestine at the camera entrance.Patient's present condition: immediate laparotomy for digestive suture and abdominal lavage.Antibiotic prophylaxis in principle.Actions taken in the care facility to manage the patient: trocar washed.Equipment kept if requested by lab.Information received from applied medical representative via email (b)(6) 2023: the patient¿s status of health is good.He stayed longer at the hospital than planned but now it is ok.Intervention: immediate laparotomy for digestive suture and abdominal lavage.Antibiotic prophylaxis in principle.Patient status: the patient¿s status of health is good.He stayed longer at the hospital than planned but now it is ok.
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: coelioscopie/laparoscopy.Event description: [translation] when the first single-use retractable-blade trocar was inserted, the blade appeared to have come out of the trocar sheath on entering the peritoneum, resulting in a wound on the small intestine at the camera entrance.Patient's present condition: immediate laparotomy for digestive suture and abdominal lavage.Antibiotic prophylaxis in principle.Actions taken in the care facility to manage the patient: trocar washed.Equipment kept if requested by lab.Information received from applied medical representative via email 24jul23: the patient¿s status of health is good.He stayed longer at the hospital than planned but now it is ok.Intervention: immediate laparotomy for digestive suture and abdominal lavage.Antibiotic prophylaxis in principle.Patient status: the patient¿s status of health is good.He stayed longer at the hospital than planned but now it is ok.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed as no damages or non-conformances were observed.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTB33, 11X100 KII SH BLD ZTHR 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17484600
• Report Number: 2027111-2023-00550
• Device Sequence Number: 20717173
• Product Code: GCJ
• UDI-Device Identifier: 00607915124250
• UDI-Public: (01)00607915124250(17)260418(30)01(10)1486285
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2026
• Device Model Number: CTB33
• Device Catalogue Number: 101476487
• Device Lot Number: 1486285
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown