MAUDE Adverse Event Report: BK MEDICAL APS (PART OF GE HEALTHCARE) LAPAROSCOPIC BK PROBE L12C4F; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	9066
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Mdr 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
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BK MEDICAL APS (PART OF GE HEALTHCARE); mileparken 34; herlev, 2730 ; DA 2730
• Manufacturer (Section G): BK MEDICAL APS (PART OF GE HEALTHCARE); mileparken 34; herlev, 2730 ; DA 2730
• MDR Report Key: 17341765
• Report Number: 3003705156-2023-00001
• Device Sequence Number: 20468917
• Product Code: ITX
• UDI-Device Identifier: 05704916000219
• UDI-Public: (01)05704916000219
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180737
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown