MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR CLPLSE90 ELECTRODE W HAND CNTRLS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 228147

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported via complaint submission tool that during an unknown procedure, two coolpulse 90 electrode with hand controls failed.No surgical delay or patient consequences reported.Additional information provided by the affiliate reported that during the procedure the electrode would not albate or coagulate while trying to cut.It was reported the case was successfully completed with a minor surgical delay and a competitor's device.The patient did not experience consequences due to the delay the products will be returned for evaluation.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary
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> according to the information provided, it was reported via complaint submission tool that during an unknown procedure, two coolpulse 90 electrode with hand controls failed.Additional information was received indicating that during surgery the doctor could not coagulate and both electrodes did not work.Both devices presented damages in the shaft.Both devices presented shaft bent condition, one of them is cracked, saline residues were observed at suction tube, signs of activation can be observed, electrode without crack in the shaft was tested, and did not presented failures.Electrodes arrived without lot number label.Both electrodes will be sent to the manufacturer for further evaluation.Supplier evaluation result for vapr clplse90 electrode w hand cntrls: two devices have been returned for investigation, the shaft on one device is snapped and the shaft on the other device badly deformed, both devices show signs of activation at tip, saline residue in suction tubes, no visible damage to the device handle, cable or plug.Device # 1 the electrical test was performed with the different parameters (active continuity, return continuity, primary capacitance, hipot active-return) as a result all test passed.The functional test was performed including different values as generator connection, flow rate and activation test, as result the flow rate was unable to perform due to bend in shaft, the remaining test were pass.Device # 2 the electrical test was performed with the different parameters (active continuity, return continuity, primary capacitance, hipot active-return) as a result primary capacitance test pass and all remaining test were fail.The functional test was performed including different values as generator connection, flow rate and activation test, as result the flow rate was unable to perform due to bend in shaft, generator connection pass and the activation test was presented an output short on ablation mode, coagulation pass.Summary: the complaint from the customer was only described as ¿failed¿.It is unclear what exactly the customer was describing but the two devices were received with one shaft badly distorted and the other partially sheared.The active tip was also dislodged from its original position but remained secure on the partially sheared device.Device 1 with the deformed shaft successfully passed all the electrical and functional tests.The flow test was not performed due to the effect the shaft distortion would have on the result.Device 2 only passed the capacitance and generator test but this would be expected considering the device condition.From the testing performed and the information received it can only be presumed that the devices were returned due to shaft distortion / partial shear and this is most likely caused by excessive mechanical force being applied to the device during the procedure.Due to the limited information provided on the event and the condition of the returned devices we are unable to determine root cause.A dhr review has been performed for both complaint lots; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.At this point, no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: VAPR CLPLSE90 ELECTRODE W HAND CNTRLS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10561156
• MDR Text Key: 207778000
• Report Number: 1221934-2020-02695
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: 10886705010097
• Combination Product (y/n): N
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 228147
• Device Catalogue Number: 228147
• Device Lot Number: U1911048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/23/2020
• Patient Sequence Number: 1