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

Model Number FB352R

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 investigation was performed using a keyence vhx-5000 digital microscope.Neither the udi-code nor the ref number can be found at the clamp.Only a "stainless germany" is visible.Several deviations can be found in the jaw serration of the clamp.Furthermore the raduis and the surface is not according to specification.According to the drawing, the radius must be 16mm, not 11mm.Conclusion and root cause: based on the information available, as well as a result of our investigation, the root cause of the failure is most probably related to third party maintenance.Rational: due to the third party maintenance, we can no longer guarantee the quality requirements of the clamp.No capa is necessary.

• Brand Name: DE'BAKEY ATR.BULLDOGCLAMP STR.20/50MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 5817640
• MDR Text Key: 50300669
• Report Number: 2916714-2016-00614
• 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: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB352R
• Device Catalogue Number: FB352R
• 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