MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A1801, 3/4 F SPRING CLIP 10/BX; DSS

Model Number A1801

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Cags - "secured mammary vessel with stealth a1801, then while working on the heart noticed excessive bleeding, when checked clamp found it had broken apart.Patient is fine." type of intervention: "the blood vessel had to be re-secured with a second clamp." patient status- "fine.".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon visual inspection, engineering confirmed that the one of the jaws of the unit had broken into three pieces.Testing was performed on inventory units from the same lot, but the customer's experience was unable to be replicated.The root cause could not be confirmed as engineering was unable to replicate the customer's experience.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: A1801, 3/4 F SPRING CLIP 10/BX
• Type of Device: DSS
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5746977
• MDR Text Key: 48823419
• Report Number: 2027111-2016-00462
• Device Sequence Number: 1
• Product Code: DSS
• UDI-Device Identifier: 00607915110734
• UDI-Public: (01)00607915110734(17)200919(30)01(10)1255529
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K883909
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/19/2020
• Device Model Number: A1801
• Device Catalogue Number: 100515901
• Device Lot Number: 1255529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Other; Required Intervention