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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.

Event Description

Procedure performed: gall bladder.Event description: complaint 1 of 3: (b)(4).Complaint 2 of 3: (b)(4).Complaint 3 of 3: (b)(4).Translation: the surgeons from the central operating theatre have discovered that the clips are missing from 3 epix ca500 disposable laparoscopic clip applicators (all the same lot: 1489898).We therefore request a replacement delivery of the goods.Additional information received from applied medical representative via complaint form on 05oct23: normal surgery setup.Every 3rd/4th clip cannot be triggered or seems to be missing.Some clips do not hold after application.Ercp (endoscopic retrograde cholangio-pancreatography) had to be performed.Additional information received from applied medical representative via email on 10oct23: the or chief said that after the ercp (endoscopic retrograde cholangio pancreatography) everything was fine.The operating room chief was not sure which intervention was done, but suspected that the doctor used a lapro-clip like he does now.For him it seemed unsafe to use our clip applier, until these problems no longer exist.The operating room chief did not know whether the clips came off the vessel before or after the transection of the vessel.All three clip appliers used were involved in this incident.Every third or forth clip of these 3 clip appliers did not come out.Additional information received from applied medical representative via email on 16oct23: the ercp was performed because one clip had become detached from the bile duct.There was no patient injury, the ercp was a precaution.The patient is all right.The detached clip was from one of the 3 ca500.The trigger could be moved as normal.The problems with the ca500 were always the same: every 3rd or 4th clip did not come out, some clips did not hold on to the vessels / ducts.Patient status: the or chief said that after the ercp (endoscopic retrograde cholangio pancreatography) everything was fine.Intervention: lapro-clip, ercp.

Event Description

Procedure performed: gall bladder.Event description: complaint 1 of 3: (b)(4).Complaint 2 of 3: (b)(4).Complaint 3 of 3: (b)(4).Translation: the surgeons from the central operating theatre have discovered that the clips are missing from 3 epix ca500 disposable laparoscopic clip applicators (all the same lot: 1489898).We therefore request a replacement delivery of the goods.Additional information received from applied medical representative via complaint form on 05oct23: normal surgery setup.Every 3rd/4th clip cannot be triggered or seems to be missing.Some clips do not hold after application.Ercp (endoscopic retrograde cholangio-pancreatography) had to be performed.Additional information received from applied medical representative via email on 10oct23: the or chief said that after the ercp (endoscopic retrograde cholangio pancreatography) everything was fine.The or chief was not sure which intervention was done, but suspected that the doctor used a lapro-clip like he does now.For him it seemed unsafe to use our clip applier, until these problems no longer exist.The or chief did not know whether the clips came off the vessel before or after the transection of the vessel.All three clip appliers used were involved in this incident.Every third or forth clip of these 3 clip appliers did not come out.Additional information received from applied medical representative via email on 16oct23: the ercp was performed because one clip had become detached from the bile duct.There was no patient injury, the ercp was a precaution.The patient is all right.The detached clip was from one of the 3 ca500.The trigger could be moved as normal.The problems with the ca500 were always the same: every 3rd or 4th clip did not come out; some clips did not hold on to the vessels/ducts.Information received from applied medical team member 26oct23: lot number was updated to 1489874 to match what was received.Patient status: the or chief said that after the ercp (endoscopic retrograde cholangio pancreatography) everything was fine.Intervention: lapro-clip, ercp.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience of incomplete clip closure could not be replicated or confirmed as all clips loaded and closed completely.The event unit passed relevant testing and no visible non-conformances were observed.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event or confirm that a product malfunction occurred.The probability and criticality of 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: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 17992151
• MDR Text Key: 326363102
• Report Number: 2027111-2023-00654
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260419(30)01(10)1489874
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• 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: 1489874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORMAL LAPRASCOPIC INTRUMENTS