MAUDE Adverse Event Report: AESCULAP AG DE'BAKEY ATR.BULLDOGCLAMP CVD.20/50MM; GENERAL SURGICAL INSTRUMENTS

Model Number FB353R

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: usa.Customer complains that the instrument is crushing the patients blood vessels because the springs are too tight.Doctor is throwing them away immediately.

Manufacturer Narrative

Investigation: the closing force of the clamp depends on the length of the spring.According to the drawing, the target length of the spring is 13.00mm, current length 13.05mm.Batch history review: the device quality and manufacturing history records have been checked for available lot number.The device history file has been checked, and found to be according to the specification valid at the time of production.No similar incidents have been filed with products from this batch.Conclusion and root cause: based on the information available as well as a result of our investigation, we exclude a material or manufacturer related error.Rational: the clamp is according to the specification.No capa is necessary.

• Brand Name: DE'BAKEY ATR.BULLDOGCLAMP CVD.20/50MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5818089
• MDR Text Key: 50299929
• Report Number: 2916714-2016-00615
• Device Sequence Number: 1
• Product Code: HXD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB353R
• Device Catalogue Number: FB353R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2016
• Date Manufacturer Received: 06/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other