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

Model Number CA500

Device Problem Failure to Fire (2610)

Patient Problem Intra-Abdominal Hemorrhage (4479)

Event Date 10/04/2023

Event Type  Injury  

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: gastric bypass.Event description: (b)(4).Information received by phone from applied medical representative 23: while getting information about complaints (b)(4), the tm was informed about a patient injury during a gastric sleeve procedure with a new order of clip appliers (ca500 lot 1490523).They had to use an extra drain, and the problem led to extra sutures and a longer procedure (45 minutes extra).The problem occurred because the clips could not be loaded by pulling the handle.The customer uses the clip applier all the time.Information from product complaint form (b)(4) 2023: patient got a drain and extra sutures.The took a second clip applier.Other laparoscopic instruments were used.Information received from surgeon via email 4oct23: translation: am now finished with a sleeve gastrectomy where we always use the applied clip appliers.Just last week we consulted with applied about problems with that instrument where sometimes clips do not come out when fired.This could be potentially dangerous (as discussed).The problems were supposedly resolved.Unfortunately.Again 2 clip appliers malfunctioned and now they did with consequences.Bleeding from a branch of the arteria epiploica dextra extending into the fat.Because of this i have: had to place an extra trocar [name redacted] for suturing.Additional clip appliers.Brand name redacted] and vicryl 2/0 sutures.Had to suture a.Epiploica dextra.Blake drain (first time in 3 years).45 minutes extra operating time.Frustration.Information received from applied medical representative via email (b)(6) 23: translation: we did not allow the artery to retract.This was an obese patient with a thick layer of fat in which the branch was located.The artery was on the edge of the section plane that had been transected with the [model name - redacted].So the clip (which did not come) was to be placed on this edge.Because the clip did not come the artery burst open and began to bleed profusely.With a large bleed in a thick layer of fat, an artery can indeed retract, allowing a haematoma to quickly form in the fat.The situation in reality is often not like in the anatomy book where you can see everything perfectly.Information received from applied medical representative via email 12oct23: translation: no clip came out when clamping causing the vein to bleed.Closing went as always, the only difference was that no clip came out.So clamping started the bleeding.There are no video/images of what occurred during the incident.Patient status: patient got a drain, extra sutures and procedure was 45 minutes longer than normal.Intervention: patient got a drain, extra sutures and procedure was 45 minutes longer than normal.Took a second clip applier.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit.However, the complainant¿s experience of no clip loaded could not be replicated or confirmed as the unit was returned locked out and functional testing was not able to be performed.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.Applied medical has issued a voluntary recall of our epix universal clip applier for specific ca500 lots.These ca500 units are being recalled due to a nonconformance that may result in a clip not loading into the jaws after the trigger is actuated.Applied medical has recently implemented manufacturing corrections which are intended to reduce the potential for this type of incident to reoccur.The lot associated with this complaint, #1490523, was included in the recall.

Event Description

Procedure performed: gastric bypass.Event description: complaint 1 of 2: (b)(4).Complaint 2 of 2: (b)(4).Information received by phone from applied medical representative 4oct23: while getting information about complaints 2023-002943 and 2023-002944, the tm was informed about a patient injury during a gastric sleeve procedure with a new order of clip appliers (ca500 lot 1490523).They had to use an extra drain, and the problem led to extra sutures and a longer procedure (45 minutes extra).The problem occurred because the clips could not be loaded by pulling the handle.The customer uses the clip applier all the time.Information from product complaint form 4oct23: patient got a drain and extra sutures.The took a second clip applier.Other laparoscopic instruments were used.Information received from surgeon via email 4oct23: translation: am now finished with a sleeve gastrectomy where we always use the applied clip appliers.Just last week we consulted with applied about problems with that instrument where sometimes clips do not come out when fired.This could be potentially dangerous (as discussed).The problems were supposedly resolved.Unfortunately.Again 2 clip appliers malfunctioned and now they did with consequences.Bleeding from a branch of the arteria epiploica dextra extending into the fat.Because of this i have: - had to place an extra trocar [name redacted] for suturing.- additional clip appliers.- [brand name redacted] and vicryl 2/0 sutures.- had to suture a.Epiploica dextra.- blake drain (first time in 3 years).- 45 minutes extra operating time.- frustration.Information received from applied medical representative via email 6oct23: translation: we did not allow the artery to retract.This was an obese patient with a thick layer of fat in which the branch was located.The artery was on the edge of the section plane that had been transected with the [model name - redacted].So the clip (which did not come) was to be placed on this edge.Because the clip did not come the artery burst open and began to bleed profusely.With a large bleed in a thick layer of fat, an artery can indeed retract, allowing a haematoma to quickly form in the fat.The situation in reality is often not like in the anatomy book where you can see everything perfectly.Information received from applied medical representative via email 12oct23: translation: no clip came out when clamping causing the vein to bleed.Closing went as always, the only difference was that no clip came out.So clamping started the bleeding.There are no video/images of what occurred during the incident.Patient status: patient got a drain, extra sutures and procedure was 45 minutes longer than normal.Intervention: patient got a drain, extra sutures and procedure was 45 minutes longer than normal.Took a second clip applier.

• 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: 17995772
• MDR Text Key: 326382231
• Report Number: 2027111-2023-00639
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)260503(30)01(10)1490523
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CA500
• Device Catalogue Number: 101474072
• Device Lot Number: 1490523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2027111-01/26/24-001-R
• Patient Sequence Number: 1
• Treatment: BLAKE DRAIN; LAPAROSCOPIC INSTRUMENTS; STRATAFIX SUTURES; THUNDERBEAT; VICRYL 2/0 SUTURES; XCEL 12 TROCAR
• Patient Outcome(s): Required Intervention