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 05/24/2022

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: lap cholecystectomy.Event description: i was on this clinic this morning to follow up with a surgeon who mentioned a cer few weeks ago.We did a first lap cholecystectomy using our clip applier and everything went good.We did a second lap cholecystectomy using our clip applier.After having properly skeletonized the cytic duct and the cystic artery, the surgeon introduced the clip applier through a 5mm kii trocar (ctf03) and placed a clip on the cystic duct.The clip was not closed properly.The surgeon took it out and placed another one which immediately crossed.He took it out and ask for another clip applier.The clip applier and the two clips are available at the pharmacy for being returned and further investigation.The surgeon squeezed the handle plastic-to-plastic, no clip over another.The surgeon placed the clip applier aside and ask for another one.With the new clip applier ca500 same lot number, he performed the procedure without any trouble.The surgeon had a grasper left hand to hold on the gallbladder and used the clip applier right hand.Intervention: change of device.Patient status: ok.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with scissored clips.Visual inspection of the clips confirmed the complainant¿s experience of scissored clips.Testing was also performed on the event unit.However, the complainant¿s experience could not be replicated as the event unit passed functional testing and no nonconformances were found during component inspection.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 cholecystectomy event description: i was on this clinic this morning to follow up with a surgeon who mentioned a cer few weeks ago.We did a first lap cholecystectomy using our clip applier and everything went good.We did a second lap cholecystectomy using our clip applier.After having properly skeletonized the cytic duct and the cystic artery, the surgeon introduced the clip applier through a 5mm kii trocar (ctf03) and placed a clip on the cystic duct.The clip was not closed properly.The surgeon took it out and placed another one which immediately crossed.He took it out and ask for another clip applier.The clip applier and the two clips are available at the pharmacy for being returned and further investigation.The surgeon squeezed the handle plastic-to-plastic, no clip over another.The surgeon placed the clip applier aside and ask for another one.With the new clip applier ca500 same lot number, he performed the procedure without any trouble.The surgeon had a grasper left hand to hold on the gallbladder and used the clip applier right hand.Intervention: change of device.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: 14649033
• MDR Text Key: 293700551
• Report Number: 2027111-2022-00629
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)250208(30)01(10)1443407
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

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 Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1443407
• 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: 05/24/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/24/2022
• Supplement Dates FDA Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2022
• 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