MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 225370

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the vapr s90 electrode 4.0mm, 90° suction w/integrated handpiece device broke.According to the report, there were no "broken pieces or fragments".It was reported that the device just began to spark in the patient's shoulder and was immediately removed.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Additional narrative: udi: (b)(4).Reporter is a j&j sales representative.The device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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-p medwatch will be filed as appropriate.Investigation summary : the complaint device was received and evaluated in juarez laboratory.Visual inspection revealed that the cable was in good condition as well as the connector and pins.The suction tube showed biological residues.The electrode tip showed signs of activation and biological residues.For further investigation, the electrode was sent to the supplier for further evaluation.The vapr s90 4.0mm w/integr hdp -ea was returned to supplier for evaluation.The supplier then conducted visual inspection, functional and electrical test of device received.The visual inspection of the device revealed that device was not returned in the original packaging.The distal tip was in a used condition with procedural debris in and around active tip, procedural residue visible in suction tube, the heat shrink at the distal end of device was damaged with section missing and no visible damage to handle, cable or plug.During functional testing the device failed the flow test due to a restriction at the distal end caused by tissue debris.The electrode ceramic and active tip were found to be intact and not damaged.Based on the information received and the heat shrink damage seen we have determined the likely cause to excessive mechanical force; therefore, no further investigation was recommended.The electrical test passed; therefore, this complaint cannot be confirmed.A dhr review has been performed for the complaint device lot number u2205134; no issues (ncrs or deviations) with the manufacturing process have been indicated which might explain the failures observed.Based on a review of the investigation findings and ra review no correction action has been implemented.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthese mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: VAPR S90 ELECTRODE 4.0MM, 90° SUCTION W/INTEGRATED HANDPIECE
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16044736
• MDR Text Key: 308358169
• Report Number: 1221934-2022-04171
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Model Number: 225370
• Device Catalogue Number: 225370
• Device Lot Number: U2205134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1