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

Model Number CA500

Device Problem Migration (4003)

Patient Problem Fluid Discharge (2686)

Event Date 08/01/2022

Event Type  Injury  

Event Description

Procedure performed: lap chole.Event description: i was not present at the time but the surgeon informed me he was using as intended squeezing plastic to plastic over vessels.Surgeon told me the event after it occurred, he was unsure exact date of event (said a couple of wees ago).Said the device worked fine on small cystic duct but this was an enlarged cystic duct that he used it on and while it seemed fine during procedure (he confirmed he squeezed plastic to plastic) the clip fell off a couple of days later.Patient is stable.Patient had to be readmitted to theatre a couple of days later.Leaked bile was removed and issue was resolved in theatre.Additional information received via email from [name] on 18 august 2022: date of the event- (b)(6) 2022.Patient status: patient is stable.Intervention: patient had to be readmitted to theatre a couple of days later.Leaked bile was removed and issue was resolved in theatre.

Manufacturer Narrative

The event device is not anticipated to return to applied medical.A follow-up report will be provided following the completion of the investigation.

Event Description

Procedure performed: lap chole.Event description: the device was squeezed plastic to plastic over vessels.Surgeon told me the event after it occurred, he was unsure exact date of event (said a couple of wees ago).Said the device worked fine on small cystic duct but this was an enlarged cystic duct that he used it on and while it seemed fine during procedure (he confirmed he squeezed plastic to plastic) the clip fell off a couple of days later.Patient is stable.Patient had to be readmitted to theatre a couple of days later.Leaked bile was removed and issue was resolved in theatre date of the event : 1st august 2022.Date that you were informed of the event happening 17th august 2022.Patient status: patient is stable.Intervention: patient had to be readmitted to theatre a couple of days later.Leaked bile was removed and issue was resolved in theatre.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is 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.Applied medical has reviewed the details surrounding the event and is unable to determine the exact root cause of the event.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: CLIPS, 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: 15419695
• MDR Text Key: 299879385
• Report Number: 2027111-2022-00730
• Device Sequence Number: 1
• Product Code: FZP
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2022
• 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
• Patient Outcome(s): Other; Hospitalization