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

Model Number CA500

Device Problem Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: "laparoscopic cholecystectomy." event description: "on (b)(6) 2022, two laparoscopic cholecystectomy cases with dr.(b)(6).During both cases, i was scrubbed in and both times the clip applier failed to eject a completely closed clip multiple times.So instead of a nice sealed clip, the clips fired looked like a horseshoe.Both of these clips came from the same box.We have used several clips since and have had no further issues.We have saved the clip appliers and have pictures of the poorly deployed clips for reference." additional information received via email on (b)(6) 2022 from name, applied medical voyant project manager: no patient injury.The rep is following up for additional information about the event.Additional information received via email on (b)(6)2022 from (b)(6), applied medical voyant project manager: the clip was fully loaded into the jaws upon actuation.The trigger was squeezed "plastic to plastic".Dr.(b)(6) fully skeletonized the vessel prior to using the clip applier.The clip applier was not used to skeletonize tissue.All of the unsealed clips were successfully removed from the patients.In the first case the clip applier had "intermittent poor clips." in the second case the clip applier "poorly fired plus applier locked up and we replaced it mid case." used a new clip applier of a different lot number to complete each case.Additional information received via email on (b)(6)2022 from (b)(6), applied medical voyant project manager: the customer provided the following information, "we used two defective clip appliers and have two to return from the same lot number 1425921." additional information received via email on (b)(6) 2022 from (b)(6], applied medical voyant project manager: "i also wanted to note that only two units of clip appliers are being sent back, not 4 (1 used device and 1 unopened with the same lot#)." "i¿ve also provided pictures of the malfunctioned clips from the used clip applier in the box as well." a photo has been provided of the malformed clip.Additional information received via phone on (b)(6) 2022 from (b)(6), applied medical voyant project manager: the other event clip applier was disposed of by the facility.Both clip appliers had issues with improper clips being fired.It is unknown which complaint clip applier will be returning and which one was disposed of.Additional information received via email on (b)(6) 2022 from (b)(6), applied medical voyant project manager: "surgeon said both units were having the same issues (clips not closing/ballooning)." "2 clip appliers experienced the same issue, only 1 is returning that experienced this issue, as the hospital discarded the other." it is unknown which clip applier provided the clips shown in the provided photo.Intervention: used a new clip applier of a different lot number to complete the case.Patient status: "patients are doing fine/no injury.".

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, a photo of the clip was provided by the customer, which confirmed the customer's experience of clips scissoring.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.

Event Description

Procedure performed: "laparoscopic cholecystectomy" event description: "on (b)(6) 2022, two laparoscopic cholecystectomy cases with [name].During both cases, i was scrubbed in and both times the clip applier failed to eject a completely closed clip multiple times.So instead of a nice sealed clip, the clips fired looked like a horseshoe.Both of these clips came from the same box.We have used several clips since and have had no further issues.We have saved the clip appliers and have pictures of the poorly deployed clips for reference." product available for return.Additional information received via email on 19apr2022 from [name], applied medical voyant project manager.No patient injury.The rep is following up for additional information about the event.Additional information received via email on 21apr2022 from [name], applied medical voyant project manager.The clip was fully loaded into the jaws upon actuation.The trigger was squeezed "plastic to plastic".[name] fully skeletonized the vessel prior to using the clip applier.The clip applier was not used to skeletonize tissue.All of the unsealed clips were successfully removed from the patients.In the second case the clip applier "poorly fired plus applier locked up and we replaced it mid case." used a new clip applier of a different lot number to complete the case.Additional information received via email on 26apr2022 from [name], applied medical voyant project manager.The customer provided the following information, "we used two defective clip appliers and have two to return from the same lot number 1425921" additional information received via email on 28apr2022 from [name], applied medical voyant project manager."i also wanted to note that only two units of clip appliers are being sent back, not 4 (1 used device and 1 unopened with the same lot#)." "i¿ve also provided pictures of the malfunctioned clips from the used clip applier in the box as well." a photo has been provided of the malformed clip.Additional information received via phone on 28apr2022 from [name], applied medical voyant project manager.The other event clip applier was disposed of by the facility.Both clip appliers had issues with improper clips being fired.It is unknown which complaint clip applier will be returning and which one was disposed of.Additional information received via email on 02may2022 from [name], applied medical voyant project manager."surgeon said both units were having the same issues (clips not closing/ballooning)." "2 clip appliers experienced the same issue, only 1 is returning that experienced this issue, as the hospital discarded the other." it is unknown which clip applier provided the clips shown in the provided photo.Intervention: used a new clip applier of a different lot number to complete the case.Patient status: "patients are doing fine/no injury.".

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 14526474
• MDR Text Key: 293175712
• Report Number: 2027111-2022-00612
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 00607915125318
• UDI-Public: (01)00607915125318(17)240804(30)01(10)1425921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1425921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• 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
• Treatment: 5MM KII FIOS 5X100.