MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX; CLIP, IMPLANTABLE

Model Number CA500

Device Problem Difficult to Insert (1316)

Patient Problem Laceration(s) (1946)

Event Date 03/06/2023

Event Type  Injury  

Event Description

Procedure performed: cholecystectomy.Event description: the clip applicator was inserted into the trocar.Set ck082 with lot number 1483966 and clip applicator ca500 were used as standard.The clip applicator was very difficult to insert into the trocar (cff03).Even moistening the clip applicator did not bring any significant improvement.The patient's liver was injured as a result of the high force used to insert the clip applicator.The liver was probably slightly injured.The chief physician assured me today that everything is fine and that it will not affect the liver or the patient's health.A second clip applicator was opened.This one had the same problems as the first clip applicator.Today (march 7th) i accompanied an operation because of what had happened.Everything went perfectly.Instruments used when complaint event occurred is kit ck082 with lot-number 1483966.Unfortunately, only the clip applicators were kept and not the trocars.Additional information received from applied medical representative via email 8mar23: the trocar is a cff12 from the kit.Additional information received from surgeon via email 8mar23: translation: i used the applied clip applier for the first time and applied as is common with the comparable clip appliers from other manufacturers that we have used so far: neither the blue handle inserted first, nor across and also not all clips outside the body already fired.The parenchymal injury was superficial and was treated with diathermy.As i am right-handed, the 5mm trocar was inserted in the left upper abdomen, other instruments were used beforehand via the port, but before clipping comes preparation.I did not use the second clip applier in the body, only ex situ through the trocar.Patient status: status is ok.The chief physician assured me today that everything is fine and that it will not affect the liver or the patient's health.Intervention: the parenchymal injury was superficial and was treated with diathermy.

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the conclusion of the evaluation.

Event Description

Procedure performed: cholecystectomy.Event description: the clip applicator was inserted into the trocar.Set ck082 with lot number 1483966 and clip applicator ca500 were used as standard.The clip applicator was very difficult to insert into the trocar (cff03).Even moistening the clip applicator did not bring any significant improvement.The patient's liver was injured as a result of the high force used to insert the clip applicator.The liver was probably slightly injured.The chief physician assured me today that everything is fine and that it will not affect the liver or the patient's health.A second clip applicator was opened.This one had the same problems as the first clip applicator.Today (march 7th) i accompanied an operation because of what had happened.Everything went perfectly.Instruments used when complaint event occurred is kit ck082 with lot-number 1483966.Unfortunately, only the clip applicators were kept and not the trocars.Additional information received from applied medical representative via email 8mar23: the trocar is a cff12 from the kit.Additional information received from surgeon via email (b)(6) 2023: translation: i used the applied clip applier for the first time and applied as is common with the comparable clip appliers from other manufacturers that we have used so far: neither the blue handle inserted first, nor across and also not all clips outside the body already fired.The parenchymal injury was superficial and was treated with diathermy.As i am right-handed, the 5mm trocar was inserted in the left upper abdomen, other instruments were used beforehand via the port, but before clipping comes preparation.I did not use the second clip applier in the body, only ex situ through the trocar.Patient status: status is ok.The chief physician assured me today that everything is fine and that it will not affect the liver or the patient's health.Intervention: the parenchymal injury was superficial and was treated with diathermy.

Manufacturer Narrative

The clip applier event units (#2027111-2023-00384 and #2027111-2023-00389) were both returned to applied medical for evaluation; however, the trocar event unit (#2027111-2023-00373) was not returned for evaluation.Visual inspection of the clip applier from complaint (b)(4) noted that the feeder was partially in the jaws and damaged, confirming the complainant¿s experience of difficulty inserting the device through the trocar.Based on the condition of this returned unit, it is likely that the reported event was caused by the feeder partially being in the jaws during passage through the trocar.It is likely that the feeder was in the jaw due to incomplete actuation of the trigger after clip loading and firing.The feeder prevented the jaws from fully collapsing during entry into the trocar, creating resistance and difficulty during device insertion.Testing was performed on the clip applier event unit from complaint #2027111-2023-00384, where the device was inserted through a representative trocar similar to the one the complainant used during the procedure.The complainant¿s experience of difficulty inserting the event unit could not be replicated or confirmed as the event unit passed through the representative trocar without difficulty.The event unit met current specifications and there were no visible non-conformances.Applied medical has reviewed the details surrounding this event and related products and is unable to determine the cause of this reported event or confirm that a product malfunction occurred.As the trocar event unit from complaint #2027111-2023-00373 was not returned, applied medical is unable to determine if that 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 is unable to determine the exact root cause of the event related to the trocar.The probability and criticality of harm resulting from these failures have been evaluated and were found to be at an acceptable level.Correction: the component code in h6 was updated to 4755 - part/component/sub-assembly term not applicable - based on the results of the investigation.

• Brand Name: CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX
• Type of Device: CLIP, IMPLANTABLE
• 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: 16576891
• MDR Text Key: 311660261
• Report Number: 2027111-2023-00384
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)250929(30)01(10)1465849
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1465849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CFF12 TROCAR; KIT CK082; OTHER INSTRUMENTS
• Patient Outcome(s): Other