MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB12, 5X100 KII SH BLD ZTHR DP 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB12
Medical Device Problem Codes	Device-Device Incompatibility (2919); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Liver Laceration(s) (1955); Needle Stick/Puncture (2462)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
Event or Problem Description
Procedure performed: lap cholecystectomy.Event description: i received a call from the pharmacist, followed by the document of an incident occurred this wednesday 13rd of march with one of our epix universal clip applier and/or/with one of our kii 5mm trocar.The problem has been described as : " sliding problem of the clip applier into the 5mm trocar".As a result of the event a injury has been mentioned regarding a liver wound.Apparently, they placed the 5mm kii trocar and the epix universal clip applier aside and they opened a new 5mm kii trocar and a new epix universal clip applier.Additional information received by applied medical rep via email on 22mar24.Patient status is ok.The nurse told that the surgeon inserted the clip applier (lot 1501033) into the 5mm kii trocar (ctb12 lot 1512234).He had some difficulty to insert into it and forced to penetrate the cavity.By forcing, he did a liver injury.He did hemostasis on the liver and the patient is ok.Then, he took the clip applier out and placed it aside.He took the trocar out and opened a new clip applier (lot 1496065) and a new 5mm kii trocar (ctb03 lot 1494707).According to the surgeon, he think the default comes from the trocar.Additional information received by applied medical rep via email on 25mar24: i also had the chance to discuss the incident directly with the surgeon and he confirms that an injury has been done by forcing the clip applier not by going through the trocar but after been into it.According to him, once in the cavity, the clip applier was not sliding smoothly as usual when in the trocar.Patient status: ok.Intervention: apparently, they placed the 5mm kii trocar and the epix universal clip applier aside and they opened a new 5mm kii trocar and a new epix universal clip applier.
Event or Problem Description
Procedure performed: lap cholecystectomy.Event description: i received a call from the pharmacist, followed by the document of an incident occurred this wednesday (b)(6) with one of our epix universal clip applier and/or/with one of our kii 5mm trocar.The problem has been described as: " sliding problem of the clip applier into the 5mm trocar".As a result of the event a injury has been mentioned regarding a liver wound.Apparently, they placed the 5mm kii trocar and the epix universal clip applier aside and they opened a new 5mm kii trocar and a new epix universal clip applier.Additional information received by applied medical rep via email on (b)(6) 2024.Patient status is ok.The nurse told that the surgeon inserted the clip applier (lot 1501033) into the 5mm kii trocar (ctb12 lot 1512234).He had some difficulty to insert into it and forced to penetrate the cavity.By forcing, he did a liver injury.He did hemostasis on the liver and the patient is ok.Then, he took the clip applier out and placed it aside.He took the trocar out and opened a new clip applier (lot 1496065) and a new 5mm kii trocar (ctb03 lot 1494707).According to the surgeon, he think the default comes from the trocar.Additional information received by applied medical rep via email on (b)(6) 2024: i also had the chance to discuss the incident directly with the surgeon and he confirms that an injury has been done by forcing the clip applier not by going through the trocar but after been into it.According to him, once in the cavity, the clip applier was not sliding smoothly as usual when in the trocar.Patient status: ok.Intervention: apparently, they placed the 5mm kii trocar and the epix universal clip applier aside and they opened a new 5mm kii trocar and a new epix universal clip applier.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.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 event have been evaluated and were found to be at an acceptable level.[correction: section d and h have been updated to reflect trocar information.].

• Brand Name: CTB12, 5X100 KII SH BLD 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
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 19112545
• Report Number: 2027111-2024-00541
• Device Sequence Number: 15366423
• Product Code: GCJ
• UDI-Device Identifier: 00607915123529
• UDI-Public: (01)00607915123529(17)261219(30)01(10)1512234
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K011236
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024
• 2 Devices were Involved in the Event: 1 2

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 Model Number: CTB12
• Device Catalogue Number: 101472911
• Device Lot Number: 1512234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLIP APPLIER (CA500); KII TROCAR (CTB12)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown