MAUDE Adverse Event Report: AESCULAP AG FINOCHIETTO RIB SPREADER 65X65MM BLDS; CARDIO-THORACIC SURGERY

Model Number FB804R

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Death (1802)

Event Date 01/19/2019

Event Type  Death  

Manufacturer Narrative

Investigation: the instrument is in a new condition, no deviation can be found with the naked eye.Vigilance investigator carried out the pictorial documentation visually (panasonic).No deviation could be found at the mint instrument, neither during functional test, nor during visual inspection.Only small scratches can be found at the tip of the blades, most likely caused by vibrations in a closed state.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers and found to be according to our specifications 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 the root cause of the failure is most probably related to an insufficient usage.Rationale: the instrument is according to the specifications, no deviations can be found at the provided instruments.Furthermore, the contact person at the hospital confirmed that the retractor was not the cause of the patient's death but the gunshot-injury.No capa is necessary.

Event Description

It was reported that the rib spreader failed intraoperatively.During a trauma case (gunshot wound to the chest) when preparing to use the finochietto retractor (rib spreader) it was noticed the retractor was assembled incorrectly, making it unusable.The retractor was disassembled before sterilization, and was noticed when the sterile tray was opened.The rotation knob was on the patient side of the retractor.As a result the surgeon needed to crack the patient's sternum.It was reported the patient died due to the fatal gunshot wound and not because of the retractor.Patient information was not provided.

Manufacturer Narrative

B5: updated.

Event Description

Further clarification received on (b)(6)2019 : date of surgery in the emergency room was 19jan2019; this was also when death occurred, during the surgery.

• Brand Name: FINOCHIETTO RIB SPREADER 65X65MM BLDS
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8356202
• MDR Text Key: 136713931
• Report Number: 9610612-2019-00106
• Device Sequence Number: 1
• Product Code: GAD
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB804R
• Device Catalogue Number: FB804R
• Device Lot Number: 52482522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Distributor Facility Aware Date: 02/08/2019
• Device Age: 1 MO
• Date Manufacturer Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death