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

Model Number 228147

Device Problems Appropriate Term/Code Not Available (3191); Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Additional product code hrx.Complainant part is not expected to be returned for manufacturer review / investigation.Occupation: no facility information available.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during a rotator cuff surgery on (b)(6) 2019, the vapr clplse90 electrode w hand cntrls did not aspirate, did not coagulate and made bubbles, making surgery difficult.Surgical delay was unknown.Another vaporizer was delivered and the surgery was completed without problems.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.H10 additional narrative: the complaint states that the device is not being returned therefore not available for evaluation, the customer is retaining the product.We cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.A manufacturing record evaluation was performed on 8/8/2019 for the finished device lot number, and no non-conformances were identified.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.At this point in time, no corrective action is required, and 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.A manufacturing record evaluation was performed on 8/8/2019 for the finished device u1901091 number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 8931502
• MDR Text Key: 161010040
• Report Number: 1221934-2019-58103
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705010097
• UDI-Public: (01)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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 228147
• Device Catalogue Number: 228147
• Device Lot Number: U1901091
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Patient Sequence Number: 1