MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSAPULSE-DISPOSBLE PULSE LAVAG SUCTION; INSTRUMENT, SURGICAL, DISPOSABLE

Model Number	W-203-B(EC)
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, when opening a versapulse-disposable pulse lavag suction box during the set-up for a tka surgery, it was found that both sterile packaging had been opened already.Surgery was resumed, without any delay, with a competitor's device (pulse lavage from zimmer - pulsavac).Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, when opening a versapulse-disposble pulse lavag suction box during the set-up for a tka surgery, it was found that both sterile packaging had been opened already.Surgery was resumed, without any delay, with a competitor's device (pulse lavage from zimmer - pulsavac).Patient was not injured as consequence of this problem.
Event or Problem Description
It was reported that, when opening two (2) versapulse-disposble pulse lavag suction boxes during the set-up for a tka surgery, it was found that both sterile packaging had been opened already.Surgery was resumed, without any delay, with a competitor's device (pulse lavage from zimmer - pulsavac).Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: this event was re-evaluated for mdr reporting.Smith+nephew does not have reporting responsibilities for this product; therefore, guangzhou, the legal manufacturer, is responsible for performing the regulatory assessment and reporting to any nca if required.

• Brand Name: VERSAPULSE-DISPOSBLE PULSE LAVAG SUCTION
• Common Device Name: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14191097
• Report Number: 1020279-2022-01924
• Device Sequence Number: 14651053
• Product Code: KDC
• UDI-Device Identifier: 06951233720279
• UDI-Public: 06951233720279
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/16/2022

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: 12/31/2023
• Device Model Number: W-203-B(EC)
• Device Catalogue Number: 97400001
• Device Lot Number: 202112211
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 03/24/2022; 03/24/2022; 03/24/2022
• Initial Report FDA Received Date: 04/23/2022
• Supplement Report FDA Received Date: 04/23/2022; 04/23/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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