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

Catalog Number	228300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) - incomplete.The expiration date is not currently available.
Event or Problem Description
During arthroscopy white part of electrode came off.Small plastic parts fell into surgery site.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, therefore is unavailable for a physical evaluation.The picture provided with the complaint information shows that the tip of the electrode is broken.The ceramic part of the electrode tip is broken and few pieces fell off which were retrieved.One of the possible root cause for this hitting instruments or hard bone surface.Other than that, we cannot determine a definitive root cause for the reported failure.A product from the same lot was returned.Visual inspection reveals the distal tip shows signs of activation.The electrode was connected to a vapr vue generator and all correct default settings were made available.The generator was set to maximum power for ablation and coagulation modes and activated in saline successfully.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.(b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.Date received by manufacturer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).¿depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.¿ udi: (b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
During arthroscopy white part of electrode came off.Small plastic parts fell into surgery site.Defective parts of impacted product are not available for investigation.Sales rep and surgeon tested an additional device from same lot and will return this for investigation.

• Brand Name: VAPR SIDE W/ HAND CONTROLS
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7605418
• Report Number: 1221934-2018-51910
• Device Sequence Number: 1590113
• Product Code: GEI
• UDI-Device Identifier: 10886705020911
• UDI-Public: 10886705020911
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/18/2018

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 Expiration Date: 12/31/2020
• Device Catalogue Number: 228300
• Device Lot Number: U1801129
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 07/10/2018; 07/10/2018; 12/20/2018; 12/20/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/01/2018; 12/17/2018; 12/21/2018; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1