• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

APPLIED MEDICAL RESOURCES A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX; CLIP, VASCULAR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9730048
MDR Text Key180125404
Report Number2027111-2020-00370
Device Sequence Number1
Product Code DSS
UDI-Device Identifier00607915115074
UDI-Public(01)00607915115074(17)240703(30)01(10)1360356
Combination Product (y/n)N
PMA/PMN Number
K883909
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/03/2024
Device Model NumberA1602
Device Catalogue Number101374001
Device Lot Number1360356
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/24/2020
Initial Date FDA Received02/19/2020
Supplement Dates Manufacturer Received01/24/2020
Supplement Dates FDA Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberNI
Patient Sequence Number1
-
-