MAUDE Adverse Event Report: BK MEDICAL APS LAPAROSCOPIC BK PROBE L12C4F; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 9066

Device Problems Material Too Rigid or Stiff (1544); Material Split, Cut or Torn (4008)

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

Event Date 12/07/2022

Event Type  malfunction  

Event Description

When inserting the bk medical laparoscopic probe the sheath covering the flexible tip tore and a piece fell in patient abdomen.This particular style probe has had this same incident happen four times now.The sheath covering is either too thin or not pliable enough to handle the insertion through a trocar.The diameter is 8mm and the trocar was 11 yet it still tore upon insertion.

• Brand Name: LAPAROSCOPIC BK PROBE L12C4F
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL APS
• MDR Report Key: 15969966
• MDR Text Key: 305496210
• Report Number: MW5113739
• Device Sequence Number: 1
• Product Code: ITX
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 159 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White