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

Model Number	A1602
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CLIP, VASCULAR
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9730046
• Report Number: 2027111-2020-00369
• Device Sequence Number: 2928202
• Product Code: DSS
• UDI-Device Identifier: 00607915115074
• UDI-Public: (01)00607915115074(17)240703(30)01(10)1360356
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K883909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2024
• 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
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1