MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MM PITUITARY INTEGRA JARIT; RONGEUR

Model Number 280415

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

Pituitary grabber instrument was being used by surgeon during procedure.Item tip bent but remained intact.Removed from sterile field.Fda safety report id# (b)(4).

• Brand Name: MM PITUITARY INTEGRA JARIT
• Type of Device: RONGEUR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 14397792
• MDR Text Key: 291815248
• Report Number: MW5109678
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 280415
• Device Catalogue Number: 280-415
• Device Lot Number: 10381780385820
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male