MAUDE Adverse Event Report: AESCULAP AG DE'BAKEY STRAIGHT FCPS 1MM TIP240MM; NON-TRAUMATIC FORCEPS, MICRO FORCEP

Model Number FB396R

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported that there are burrs on serrations.

Manufacturer Narrative

Investigation: the investigation was performed using a keyence vhx-5000 digital microscope.According to the supplier quality manager after evaluation, the forceps are according to the specification.No burrs can be found, though, due to repression of the material, bugles are recognizable.Furthermore it is noticable that the teeth are not fully developed and not symmetrical.Batch history review: the device quality and manufacturing history records have been checked for all available lot numbers.The device history file has been checked and found to be according to our specificaiton valid at the time of production.Seven similar incidents have been filed with products from these batches.Conclusion and root cause: based on the information available as well as a result of our investigation the products are according to our specificaiton valid at the time of production.A capa regarding the surface of the instruments has already been initiated.

• Brand Name: DE'BAKEY STRAIGHT FCPS 1MM TIP240MM
• Type of Device: NON-TRAUMATIC FORCEPS, MICRO FORCEP
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7334576
• MDR Text Key: 102314275
• Report Number: 9610612-2018-00109
• Device Sequence Number: 1
• Product Code: HTD
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB396R
• Device Catalogue Number: FB396R
• Device Lot Number: 4508798187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Distributor Facility Aware Date: 03/07/2018
• Device Age: 7 MO
• Date Manufacturer Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other