MAUDE Adverse Event Report: JOIMAX GMBH VAPORFLEX BIPOLAR; ELECTROSURGICAL PROBE

Model Number JVP32024

Device Problems Degraded (1153); Material Frayed (1262); Melted (1385); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/14/2022

Event Type  Injury  

Event Description

A surgeon reported the following event information involving two joimax vaporflex bipolar probes that were used on the same patient."when working with the bipolar coagulation probe from joimax during endoscopic spinal interventions, the heat causes recurring temperatures at the tip of the bipolar probe, which lead to charring of the plastic coating of the probe, which means that small plastic particles get into the situs.Additionally, in the current surgery the bipolar focal tip broke, so that the metal part came to rest in the situs and had to be recovered at great expense.An intraoperative photo was taken for documentation, and the two probes used were also kept.Problems with the probes recur after just a short period of use.So far, this has not caused any damage to the patient.".

Manufacturer Narrative

The two (2) model jvp32024 vaporflex® probe, bipolar, ball tip 320 devices used on this patient were returned to the manufacturer for evaluation and subjected to microscopic visual examination and comparison to a control probe (same device model) that had been previously cycled to maximum simulated use.For purposes of this investigation summary, the 2 devices returned for evaluation are being referred to as probe 1a and probe 1b.The findings for both returned bipolar probes revealed wear and degradation of the electrodes; however, the metal tips were both intact and there are no signs of missing metal fragments in either device.Specifically, the probe heads showed thermal wear consisting of vaporized isolation between the two metal electrodes.The isolation tubing directly adjacent to the probe heads showed shrinkage/fraying which is consistent with findings for devices that have been subjected to overheating.Probe 1a (the subject of this mdr) showed stronger signs of vaporization on the probe head and more extensive shrinkage/fraying for the isolation tubing directly adjacent to the probe head when compared to probe 1b.The control probe was subjected to worst-case use conditions (20 minutes at maximum power) in accordance with the instructions for use and there was almost no visible sign of wear.Based on the microscopic examination findings and analysis of the intraoperative photo image, the manufacturer is unable to confirm that the alleged reported "metal parts" originated from the vaporflex probes.Both probes were from the same manufacturing lot.The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings that relate to the reported event.In addition, there were no similar complaints associated with this lot number.The device instructions for use include the following pertinent warning statements: "the probe must not be used for continuous operation under any circumstances! after 30 seconds of use, there must be a pause of at least 2 seconds!" "during use, especially when using higher power, the head of the probe must be regularly checked for signs of wear! when initial signs of wear appear, the entire probe must be replaced by a new one!" based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.After conducting a thorough investigation and discussing the event with the physician during retraining, the root cause was identified as use error where the probes were used continuously without pausing to prevent overheating.The device damage observed is a direct result of continuous use.This mdr is for the first probe involved in the event (probe 1a); refer to mdr # 3005083075-2022-00002 for the second probe (probe 1b).Manufacturer reference #: (b)(4).

• Brand Name: VAPORFLEX BIPOLAR
• Type of Device: ELECTROSURGICAL PROBE
• Manufacturer (Section D): JOIMAX GMBH; amalienbadstrasse 41; raumfabrik 61; 76227 karlsruhe, ; GM
• Manufacturer (Section G): JOIMAX GMBH; amalienbadstrasse 41; raumfabrik 61; 76227 karlsruhe, ; GM
• Manufacturer Contact: jens widmann ; amalienbadstrasse 41; raumfabrik 61; 76227 karlsruhe, ; GM
• MDR Report Key: 13841497
• MDR Text Key: 287575636
• Report Number: 3005083075-2022-00001
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JVP32024
• Device Lot Number: 136/952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male