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

Model Number CA500

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Injury (2348)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow up report will be sent once the results have been analyzed.

Event Description

Procedure performed: lap.Cholecystectomy."dr stated clip applier misfired 3x during procedure.It is not known at this time if it misfired on first actuation or subsequent.Also not known if they used more than one clip applier.After the procedure in the recovery room, the patient became hypotensive and had to go back to surgery.It was discovered she bled 1.5 l of blood into her belly from cystic artery.Not known at this time if clips were still on vessel during 2nd procedure." additional information received via email from account manager, on monday, (b)(6) 2019 "i¿m in the process of meeting with the dr.To further discuss this event.As soon as i have more information, i will let you know." additional information received via email from account manager, on thursday, (b)(6) 2019.The patient is fine.The clips couldn't be confirmed during the 2nd procedure if still on the vessel.Due to the post-op bleeding, a blood clot formed over the cystic artery and the presence of a clip or absence couldn't be confirmed.The device isn't returning because it wasn't saved after the first procedure.They used the same clip throughout the first procedure.No lot number was recorded.They used the 5mm trocar.No video, photo.During the case the clip applier misfired twice (spitting) while ligating the cystic artery.The misfires occurred after the cystic duct was ligated.After the two misfires, the cystic artery(patient side) was ligated twice and 1 clip was applied to the specimen side of the cystic artery.Medwatch (b)(4) received via mail on 04jun2019.Patient info: (b)(6) yrs, not hispanic/latino.Date of event: (b)(6) 2019.While completing laparoscopic chole, physician was attempting to seal vessel with hemaclip, and applier misfired 3x before properly firing a clip.Physician believes the clip that was eventually placed did not seal the vessel, causing patient to develop hematoma and return to surgery for evacuation.There were issues with this equipment approximately 6 months ago, which were not reported to risk management but to the manufacturer.Laparoscopic cholecystectomy.Patient status: the patient is fine.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation, and the lot number was not provided.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.

Event Description

Procedure performed: lap.Cholecytectomy "dr stated clip applier misfired 3x during procedure.It is not known at this time if it misfired on first actuation or subsequent.Also not known if they used more than one clip applier.After the procedure in the recovery room, the patient became hypotensive and had to go back to surgery.It was discovered she bled 1.5 l of blood into her belly from cystic artery.Not known at this time if clips were still on vessel during 2nd procedure.".Additional information received via email from account manager, on monday, (b)(6) 2019 "i¿m in the process of meeting with the dr.To further discuss this event.As soon as i have more information, i will let you know.".Additional information received via email from account manager, on thursday, 23may2019 the patient is fine.The clips couldn't be confirmed during the 2nd procedure if still on the vessel.Due to the post-op bleeding, a blood clot formed over the cystic artery and the presence of a clip or absence couldn't be confirmed.The device isn't returning because it wasn't saved after the first procedure.They used the same clip throughout the first procedure.No lot number was recorded.They used the 5mm trocar.No video, photo.During the case the clip applier misfired twice (spitting) while ligating the cystic artery.The misfires occurred after the cystic duct was ligated.After the two misfires, the cystic artery(patient side) was ligated twice and 1 clip was applied to the specimen side of the cystic artery.Medwatch (b)(4) received via mail on 04jun2019.Patient info: 27 yrs, not hispanic/latino.Date of event: (b)(6) 2019.While completing laparoscopic chole, physician was attempting to seal vessel with hemaclip, and applier misfired 3x before properly firing a clip.Physician believes the clip that was eventually placed did not seal the vessel, causing patient to develop hematoma and return to surgery for evacuation.There were issues with this equipment approximately 6 months ago, which were not reported to risk management but to the manufacturer.Laparoscopic cholecystectomy patient status: the patient is fine.

• 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
• MDR Report Key: 8685426
• MDR Text Key: 147568503
• Report Number: 2027111-2019-00474
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR