MAUDE Adverse Event Report: MILLENNIUM / INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS. MILLENNIUM PRATT RECTAL PROBE 73/4 SILVER; SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Model Number 1-475335

Device Problem Break (1069)

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

Event Date 01/30/2023

Event Type  Injury  

Event Description

A piece of the rectal probe broke off during a rectal exam under anesthesia.The piece was found and removed from the pt's rectum.See scanned pages.

• Brand Name: MILLENNIUM PRATT RECTAL PROBE 73/4 SILVER
• Type of Device: SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)
• Manufacturer (Section D): MILLENNIUM / INSTRUMED INTERNATIONAL INC., DBA AVALIGN GERMAN SPECIALTY INSTRUMENTS.
• MDR Report Key: 16312191
• MDR Text Key: 309053289
• Report Number: MW5114735
• Device Sequence Number: 1
• Product Code: KOA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2023

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: 1-475335
• Device Lot Number: 508230(2)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White