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

Model Number 9066

Device Problem Device Handling Problem (3265)

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

Event Date 12/07/2022

Event Type  Injury  

Manufacturer Narrative

The probe itself was evaluated and bk medical did not find either a manufacturing defect or a malfunction.The investigation concluded that there is a high likelihood that the damaged flexible sheath is a result of mishandling of the transducer either 1) when sterilizing the transducer or 2) when retracting the transducer in a bend position or due to a combination of the two potential causes.All identified risk scenarios have been addressed in the product risk assessment and been mitigated to an acceptable level.The two potential causes are already addressed as cautions and warnings in the device user guide and user guide for care and cleaning.There is a low risk of any biological reactions to the patient.

Event Description

Mor report mw5113739.Received by bk medical 16-dec-2022.Event description: when inserting the bk medical laparoscopic probe the sheath covering the flexible tip tore and a piece fell in patient abdomen.

• Brand Name: LAPAROSCOPIC BK PROBE L12C4F
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC, PRODUCT CODE: ODG
• Manufacturer (Section D): BK MEDICAL APS; mileparken 34; herlev, 2730 ; DA 2730
• MDR Report Key: 17443876
• MDR Text Key: 320236789
• Report Number: 3008194047-2023-12345
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 05704916000219
• UDI-Public: 05704916000219
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2023,08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9066
• Device Catalogue Number: L12C4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other