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 02/04/2019

Event Type  Injury  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure: cholecystectomy the surgeon ask me, that he have with 3 young men's by the gallbladder revisions because the clips don't keep on the artery and cysticus.Additional information received from sales representative via email on 08feb2019: the clips were no longer on the cystic duct and cystic artery during the revision-surgery.The doctor wants to monitor it, because there was nothing unusual during lap.Sigmoid resections the customer has been trained on the correct use of the device and has assured me of this again; it was squeezed plastic to plastic ¿ as taught during the training; skeletonization is done in this hospital with a dissector, clip appliers are only used for vessels.The customer thinks that these incidents could be explained because of the young, athletic patients.Patient status: home.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation, along with two fired clips.Testing was performed on the event unit.The returned clips were visually inspected.While one clip was fully closed, the other appeared to have been clipped over a tubular structure.However, the exact circumstances that led to the condition of the returned clips could not be determined, as the event unit met current specifications, and there no visible non-conformances.Based on the condition of the returned unit, the returned clips, and description of the event, the exact root cause of the reported event could not be confirmed.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible enhancements intended to further minimize the potential for this type of event to occur.

Event Description

Procedure: cholecystectomy.The surgeon ask me, that he have with 3 young men's by the gallbladder revisions because the clips don't keep on the artery and cysticus.Additional information received from sales representative via email on 08feb2019: the clips were no longer on the cystic duct and cystic artery during the revision-surgery.The doctor wants to monitor it, because there was nothing unusual during lap.Sigmoid resections 1.The customer has been trained on the correct use of the device and has assured me of this again 2.It was squeezed plastic to plastic ¿ as taught during the training 3.Skeletonization is done in this hospital with a dissector, clip appliers are only used for vessels.The customer thinks that these incidents could be explained because of the young, athletic patients.Additional information received from sales representative by email on 08apr2019: questions: 1.Can you please confirm that the returned unit is from the original lap cholecystectomy? 2.Two fired clips were also found in the bag with the unit, can you please confirm that these clips correspond to the returned unit? 3.The returned unit was locked out, with no clips remaining, can you please confirm whether all clips were used during the procedure or if the device was fired after the procedure was completed? response: 1.Yes- it was an unsteril clipper from a lap cholecystectomy.2.The two clips are from the clipper in the bag.3.Not all clips are fired for the indication.The surgeon testet after with me and presentat it.Patient status: home.

• 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: 8384178
• MDR Text Key: 137666357
• Report Number: 2027111-2019-00373
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)211126(30)01(10)1342922
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: CA500
• Device Catalogue Number: 101471777
• Device Lot Number: 1342922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization