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 Laceration(s) (1946)

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the evaluation.

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 applied medical 5mm adv fixation trocar, when incident happened when mobilizing the gallbladder.Describe the event, including any relevant information that might impact the investigation the clip severed the cystic duct by 'scissoring', meaning the two distal ends of the clip didn't appose, but crossed over damaging the duct.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, but duct ligated with endoloop instead of clip.How did the user resolve the situation (e.G.Was the device replaced or was additional intervention required)? clip removed and endoloop used instead.What other instruments (if any) were used when the complaint event occurred? endoloop.Intervention: clip removed and endoloop used instead.Patient status: cystic duct was severed.The duct was ultimately secured and ligated with an endoloop, and patient ok.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with three clips.Visual inspection of the returned clips confirmed the complainant¿s experience of scissored clips as one of the clips was scissored.Functional testing was also performed on the returned unit, all remaining clips closed properly when fired.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 applied medical 5mm adv fixation trocar, when incident happened when mobilizing the gallbladder describe the event, including any relevant information that might impact the investigation the clip severed the cystic duct by 'scissoring', meaning the two distal ends of the clip didn't appose, but crossed over damaging the duct.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, but duct ligated with endoloop instead of clip.How did the user resolve the situation (e.G.Was the device replaced or was additional intervention required)? clip removed and endoloop used instead.What other instruments (if any) were used when the complaint event occurred? endoloop intervention: clip removed and endoloop used instead.Patient status: cystic duct was severed.The duct was ultimately secured and ligated with an endoloop, and patient 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 Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14649792
• MDR Text Key: 301247713
• Report Number: 2027111-2022-00630
• 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: APPLIED MEDICAL 5MM ADV FIXATION TROCAR; ENDOLOOP