MAUDE Adverse Event Report: COOK ENDOSCOPY QUICKSILVER BIPOLAR COAGULATION PROBE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number BCP-7B

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: erbe generator (unknown model).Investigation evaluation: our evaluation of the product said to be involved confirmed that wires are exposed.The cautery tip on the probe has separated from the catheter.The device was returned to the supplier and we are currently waiting for a full evaluation.A follow up report will be sent when the supplier evaluation has been completed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusions: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Instruction for use state, "visually inspect with particular attention to kinks, bends, and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." instructions for use give the user the following directions for testing the device, "immerse distal tip of probe in saline, then remove.Immediately after removing tip from water source, activate generator to test probe.Note: water should bubble on tip of probe.If an abnormality is detected which would prohibit proper working condition, do not use." damage to the probe tip can occur if the distal end of the endoscope is deflected more than fifteen (15) degrees when the bipolar probe is advanced or withdrawn from the accessory channel of the endoscope.The instructions for use warn the user not to pass the probe through an endoscope whose distal end is deflected at an angle more than approximately fifteen (15) degrees.Prior to distribution, all quicksilver bipolar coagulation probes are subjected to a visual inspection to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

Event Description

During an upper endoscopy, the physician used a cook quicksilver bipolar coagulation probe.The cautery tip on the probe separated from the catheter.Also, there were wires showing at the separation.A new cook quicksilver bipolar coagulation probe was opened and used to complete the procedure.Upon receiving the device for evaluation on 01/13/2016, it was found that the tip of the probe is still attached to the device; however, there were wires still showing.Therefore, due to exposed wires, this is being reported out of an abundance of caution.

Event Description

This follow up report is being sent to cancel the initial report submitted relating to this event because additional information was provided.Please reference below for justification.The following was reported to cook on 12/30/2016: during an upper endoscopy, the physician used a cook quicksilver bipolar coagulation probe.The cautery tip on the probe separated from the catheter.Also, there were wires showing at the separation.A new cook quicksilver bipolar coagulation probe was opened and used to complete the procedure.Upon receiving the device for evaluation on 01/13/2016, it was found that the tip of the probe is still attached to the device; however, there were wires still showing.Therefore, due to exposed wires, this event was reported out of an abundance of caution.Clarification was received from clinical personnel at the cook supplier on 02/11/2016; the clarification is as follows: the only time that current would be passing through the probe would be when the electrical generator was triggered; with the physician monitoring the procedure the entire time on the monitor, risk for unintended burns due to exposed wires is highly unlikely.Based on this clinical clarification from the supplier, as the risk to the patient is unlikely, this is no longer a reportable event.

• Brand Name: QUICKSILVER BIPOLAR COAGULATION PROBE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 5383033
• MDR Text Key: 36512072
• Report Number: 1037905-2016-00012
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BCP-7B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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