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

Model Number	A1801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/17/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.".
Additional 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
• Common Device Name: DSS
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5746977
• Report Number: 2027111-2016-00462
• Device Sequence Number: 10810646
• Product Code: DSS
• UDI-Device Identifier: 00607915110734
• UDI-Public: (01)00607915110734(17)200919(30)01(10)1255529
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K883909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 02/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention