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

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

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: lap chole event description: how was the device being used/what action was being performed when the event occurred? clip applier used in conjunction with cff03, and surgeon has used this port before.Describe the event, including any relevant information that might impact the investigation the clip 'crossed over' effectively not closing properly.Clip distal ends not opposing properly.Were there any changes in health resulting from the event (e.G.Clinical signs, symptoms, conditions, or overall health impact)? if so, please explain no.How did the user resolve the situation (e.G.Was the device replaced or was additional intervention required)? remove clip and endoloop used.What other instruments (if any) were used when the complaint event occurred? endoloop.Additional information: additional information received via email on (b)(6) 2022 from [name]: 1.Did the surgeon torque the jaws on vessel or tubular structure? no.2.Was the clip closed over thick/dense tissue? - no it was a thin cystic duct.3.Were the jaws located completely around the vessel or structure to be ligated? yes.4.Did the surgeon skeletonize the tissue with the jaws? no - a clip is never applied prior to cystic duct being ready.Also - the applier even has to be pushed quite hard to get down the balloon ports which i use as standard.Additional information received via email on (b)(6) 2022 from applied medical territory manager: the customer is unable to provide any further information with regard to the questions our team asked for this incident.Intervention: removed the clip and endoloop used.Patient status: ok.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with two closed clips.Visual inspection was performed on the returned unit and clips, confirming the clips were closed incompletely.Functional testing was also performed on the event unit, where all remaining clips loaded and closed properly.As the event unit passed functional testing and the returned clips were found to be incompletely closed rather than scissored, the complainant¿s experience of scissored clips could not be replicated or confirmed.Based on the condition of the returned unit and the event description, the root cause of the reported event could not be determined.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: lap chole event description: how was the device being used/what action was being performed when the event occurred? clip applier used in conjunction with cff03, and surgeon has used this port before.Describe the event, including any relevant information that might impact the investigation the clip 'crossed over' effectively not closing properly.Clip distal ends not opposing properly.Were there any changes in health resulting from the event (e.G.Clinical signs, symptoms, conditions, or overall health impact)? if so, please explain no how did the user resolve the situation (e.G.Was the device replaced or was additional intervention required)? remove clip and endoloop used what other instruments (if any) were used when the complaint event occurred? endoloop additional information received via email on 26 may 2022 from [name]: 1.Did the surgeon torque the jaws on vessel or tubular structure? no 2.Was the clip closed over thick/dense tissue? - no it was a thin cystic duct 3.Were the jaws located completely around the vessel or structure to be ligated? yes 4.Did the surgeon skeletonize the tissue with the jaws? no - a clip is never applied prior to cystic duct being ready also - the applier even has to be pushed quite hard to get down the balloon ports which i use as standard.Additional information received via email on 26 may 2022 from applied medical territory manager: the customer is unable to provide any further information with regard to the questions our team asked for this incident.Intervention: removed the clip and endoloop used patient status: ok.

• 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 (Section G): 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: 14649048
• MDR Text Key: 301357284
• Report Number: 2027111-2022-00628
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)220905(30)01(10)1368724
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1368724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• 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: (B)(4).; CFF03