MAUDE Adverse Event Report: AESCULAP AG CASPAR RONGEURUP-BITESERR 3MM160MM; BONE PUNCHES, RONGEURS

Model Number FF543R

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

If additional information or evaluation results become available, a supplemental report will be submitted.

Event Description

It was reported that there was an issue with caspar rongeurup-biteserr 3mm160mm.According to the complaint description, the instrument was bent during it´s first use after purchising.Surgeon grasped spinal discus tissue.There was no patient harm.Additional information was not provided nor available.The adverse event / malfunction is filed under (b)(4).

Manufacturer Narrative

Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

Event Description

The adverse event / malfunction is filed under aag reference (b)(4).

• Brand Name: CASPAR RONGEURUP-BITESERR 3MM160MM
• Type of Device: BONE PUNCHES, RONGEURS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10515619
• MDR Text Key: 206859844
• Report Number: 9610612-2020-00506
• Device Sequence Number: 1
• Product Code: HTX
• 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: 04/13/2021

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: FF543R
• Device Catalogue Number: FF543R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 01/01/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1