MAUDE Adverse Event Report: AESCULAP AG MICRO-HALSTED FORCEPS DEL CVD 125MM; HAEMOSTATIC FORCEPS

Model Number BH109R

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with micro-halsted forceps.According to the complaint description the tip broke during surgery.No complications during surgery another instrument was used.There was no patient harm.Additional information has been requested but not yet received as of this report.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

We made a visual inspection of the product and of the fracture surface.Here we found rainbow colored discoloration and yellow-brown, brown and blue discolorations, cracks, secondary damages and signs of an intercrystalline fracture.Additionally we made an optical inspection of the broken off part.Here we detected different chamfers.Furthermore we made a visual inspection of the fracture surface.Here we found brown, blue and dark discoloration, cracks and signs of an intercrystalline fracture.Based on the information available, a final root cause could not be determined.There might be a combination of a multiple factors error that leads to the fracture.

• Brand Name: MICRO-HALSTED FORCEPS DEL CVD 125MM
• Type of Device: HAEMOSTATIC FORCEPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10586347
• MDR Text Key: 208558980
• Report Number: 9610612-2020-00574
• Device Sequence Number: 1
• Product Code: HRQ
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BH109R
• Device Catalogue Number: BH109R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1