MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR P50 W/ HAND CONTROLS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE

Model Number 228504

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).Investigation summary: according to the information provided, it was reported that during the acl operation, after connecting with generator, does not function at all, the screen did now show any alert code.The complaint device was received and evaluated.Visual inspections revealed signs of activation and saline residues into the suction tube.No visual damaged found in the shaft and cord.It did not work during ablate, and coagulate test and not appeared any message during the modes.Therefore, the device was sent to supplier for further evaluation.Supplier evaluation result for vapr p50 w/ hand controls: the device has not been returned in its original packaging.The active tip of the electrode does not show any signs of obvious activation.Also, there are saline residues visible in suction tube.Finally, the electrode shaft, handle, cable and plug does not show any signs of damage.Supplier summary: the customers claim of the device not working was substantiated.The break in continuity was located across the electrical crimp.The device did not activate on cut or coag modes initially.However, after a period of 3 seconds, the device activated without issue.The active continuity measurement was re-measured and found to be within specification.From our investigation we were able to confirm the customer reported defect, the returned device were found to exhibit intermittent connection in continuity across the electrical crimp contained within the handle.A capa investigation cap was initiated to investigate the intermittent connection within the device handle, it was implement to prevent occurrence of this defect.This cap has since been closed in 2019.The complaint device was manufactured prior to the design change.A manufacturing record evaluation was performed for the finished device lot number: u1907021, and no non-conformances related to the reported complaint condition were identified.At this point in time, 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.Initial reporter phone number: (b)(6).Udi:(b)(4).

Event Description

It was reported that during the acl operation, after connect with generator, does not function at all, the screen did now show any alert code.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• Brand Name: VAPR P50 W/ HAND CONTROLS
• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10693421
• MDR Text Key: 211919061
• Report Number: 1221934-2020-03043
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705020942
• UDI-Public: 10886705020942
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 228504
• Device Catalogue Number: 228504
• Device Lot Number: U1907021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1