MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR COOLPULSE90 ELECTRODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228146
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11.Additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.According to the information provided, it was reported that during the surgery, the electrode pad at the front end of the blade fell off.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The product was not returned to depuy synthes; however, a photo was provided for evaluation.The photo was reviewed by the manufacturer with the following result: the fault with the image seems to be consistent with the fault investigated in capa.The capa report stated that the most probable root causes which would attribute to this fault method would be either: the weld bridge on active suction tube is providing sufficient weld material and retention.Mechanical fatigue due to stress corrosion pitting/corrosion and due to welding process.Misuse (eg.Extended activation, or overloading of mechanical forces).The action taken as a result of this capa are that a new active suction tube was introduced in 2015 under (b)(4).The overall complaint was confirmed as the observed condition of the vapr coolpulse90 electrode would have contributed to the complained device issue.Based on the investigation findings, the potential cause is undetermined.Depuy synthes will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Manufacturer photo evaluation: capa-101220.Device history review: given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.E1: the reporter¿s complete facility address was not provided.
Event or Problem Description
It was reported that during unknown arthroscopic procedure that the vapr coolpulse90 electrode device electrode pad at the front end of the blade fell off.Another device was used to complete the procedure.There was no delay in the procedure reported.There were no adverse patient consequences reported.All available information has been disclosed.

• Brand Name: VAPR COOLPULSE90 ELECTRODE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24642475
• Report Number: 1221934-2026-01162
• Device Sequence Number: 21281275
• Product Code: GEI
• UDI-Device Identifier: 10886705010080
• UDI-Public: (01)10886705010080(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 228146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown