MAUDE Adverse Event Report: AESCULAP AG GLOVER ATR.CLAMP CVD 215MM; NON-TRAUMATIC HAEMOSTATIC FORCEPS

Model Number FB458R

Device Problem Defective Device (2588)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that during a renal transplantation procedure, a surgeon was using a device to clamp the vena cava.The device did not function properly and did not stop the blood flow and the patient started to hemorrhage which caused cardiac arrest by hypovolemic shock.

• Brand Name: GLOVER ATR.CLAMP CVD 215MM
• Type of Device: NON-TRAUMATIC HAEMOSTATIC FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6675349
• MDR Text Key: 78805420
• Report Number: 9610612-2017-00344
• Device Sequence Number: 1
• Product Code: HXD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB458R
• Device Catalogue Number: FB458R
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/26/2017
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other