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

Model Number CA500

Device Problem Failure to Fire (2610)

Patient Problem Laceration(s) (1946)

Event Date 11/16/2021

Event Type  Injury  

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 Description

Procedure performed: laparoscopic cholecystectomy.Event description: "dr.[name] used the first clip on the duct leading to the gallbladder.After applying the clip, he went to remove the applier and the clip stuck in the applier and ripped the gallbladder.New staff did not save the wrapper for lot #, but applier is available for evaluation.Surgeon asked for another clip applier and would not use this one again to see if the problem would be duplicated." product is available for return.Additional information received via email on 09dec2021 from [name], [user facility] manager, value analysis: the patient has been discharged from the hospital.There was bile leakage.There was no excess bleeding caused as a result of the event.The ripped gallbladder was address with "another clipper".The clip applier was used through an "applied 5mm balloon" trocar.The device jammed in the closed position.It is unknown if the surgeon noted the jaws releasing the clip after the clip application.Intervention: used another clip applier to complete the case.Patient status: "ripped the gallbladder", there was bile leakage, patient has been discharged.

Event Description

Procedure performed: laparoscopic cholecystectomy event description: "dr.[name] used the first clip on the duct leading to the gallbladder.After applying the clip, he went to remove the applier and the clip stuck in the applier and ripped the gallbladder.New staff did not save the wrapper for lot #, but applier is available for evaluation.Surgeon asked for another clip applier and would not use this one again to see if the problem would be duplicated." product is available for return.Product is available for return.Additional information received via email on 09dec2021 from [name], [user facility] manager, value analysis: the patient has been discharged from the hospital.There was bile leakage.There was no excess bleeding caused as a result of the event.The ripped gallbladder was address with "another clipper".The clip applier was used through an "applied 5mm balloon" trocar.The device jammed in the closed position.It is unknown if the surgeon noted the jaws releasing the clip after the clip application.Intervention: used another clip applier to complete the case.Patient status: "ripped the gallbladder", there was bile leakage, patient has been discharged.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical was 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.The probability and criticality of the harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 12995045
• MDR Text Key: 286752385
• Report Number: 2027111-2021-00773
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: "APPLIED 5MM BALLOON" TROCAR
• Patient Outcome(s): Other