MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX; CLIP, VASCULAR

Model Number A1602

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: ni.The clip remained blocked in the open position when the surgeon wanted to clamp the mammary artery.Clinical consequence: none.This incident took place at the ctcv block on (b)(6) 2020 and on (b)(6) 2020.Original : le clip est resté bloqué en position ouverte lorsque le chirurgien a voulu clamper l'artère mammaire.Conséquence clinique : aucune.Cet incident a eu lieu au bloc ctcv le (b)(6) 2020 et le (b)(6) 2020.Intervention: ni.Patient status: clinical consequence: none.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable be performed and the complainant¿s experience could not be replicated or confirmed.Based on the event description and previous events that were reported to applied, it is likely that the reported event was caused by interference between the male and female jaw components.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has recently implemented process enhancements intended to further minimize the potential for this type of event to occur.

Event Description

The clip remained blocked in the open position when the surgeon wanted to clamp the mammary artery.Clinical consequence: none.This incident took place at the ctcv block on (b)(6) 2020 and on (b)(6) 2020.Original : le clip est resté bloqué en position ouverte lorsque le chirurgien a voulu clamper l'artère mammaire.Conséquence clinique : aucune.Cet incident a eu lieu au bloc ctcv le (b)(6) 2020 et le (b)(6) 2020.Clinical consequence: none.

• Brand Name: A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX
• Type of Device: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9730048
• MDR Text Key: 180125404
• Report Number: 2027111-2020-00370
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 00607915115074
• UDI-Public: (01)00607915115074(17)240703(30)01(10)1360356
• Combination Product (y/n): N
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1602
• Device Catalogue Number: 101374001
• Device Lot Number: 1360356
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NI
• Patient Sequence Number: 1