MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 4.0MM W/INTEGR HDP -EA; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Catalog Number 225370

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).

Event Description

It was reported by the affiliate via phone that during an acl reconstruction the vapr s90 4.0 mm w/integr hdp ea was connected to the generator and it did not cut and it did not coagulate.There was no alert code shown on the screen.The procedure was completed using another device.No patient consequence and no surgical delay was reported.No additional information was provided in house laboratory testing found the returned device displayed output short errors when activated.The device was sent to the supplier for an in-depth investigation.

Manufacturer Narrative

(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.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.Investigation summary: the device was received and evaluated.The complaint cannot be confirmed.It was observed that the active tip of the device appeared activated and saline residue was present in the suction tubing indicating that the device had been previously used.No anomalies on cord, tip housing.The device was connected to a test generator to test the functionality of the device.The device was activated in both ablate and coagulate modes for several seconds,initially ablate displayed output short error, then function the device was forwarded to the manufacturer for further investigation into the observed failures.The manufacturer indicated that the device as presented showed some signs of clinical use due to the presence of residue within the suction port and the active tip having a small level of erosion.The device passed continuity and capacitance checks but initially failed a hipot test, possibly due to residue tracking over the ceramic.A subsequent hipot test after a cleaning process passed.The original customer complaint states that there is no output on either ablate or coagulation.The device received for investigation activated as expected except for 3 brief output short errors which only lasted <1 second each indicating an intermittent high current flow but not leading to the device becoming unusable.Previous one piece lps electrodes (s90) seen which exhibit similar failure mode including output shorting, manifold melting, sparking and arcing during a surgical procedure have been further investigated through capa.Please refer to capa investigation closure report attachment.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified.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.Udi:(01)10886705009398(10)u1812011(17)211130.

• Brand Name: VAPR S90 4.0MM W/INTEGR HDP -EA
• 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: 9355396
• MDR Text Key: 203491860
• Report Number: 1221934-2019-59668
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: 10886705009398
• Combination Product (y/n): N
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

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: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 225370
• Device Lot Number: U1812011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/20/2019
• Supplement Dates FDA Received: 12/23/2019
• Patient Sequence Number: 1