MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE SOLO SUCTION IRRIGATOR; LAVAGE, JET

Catalog Number	0067570
Medical Device Problem Codes	Inability to Irrigate (1337); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure on (b)(6) 2021, the bard/davol simpulse solo device was used.The device failed to drain water suddenly.It was reported that the saline was not discharged from the device (the device failed to irrigate) during test.There was no reported patient injury.Sample return evaluation found the battery latch had detached from the battery case.
Additional Manufacturer Narrative
As reported, the simpulse solo device failed to irrigate suddenly during the procedure.The subject device was returned for evaluation.Initial evaluation of the sample is performed and found that there is irrigation fluid inside of the irrigation tubing indicating fluid was introduced into the system.The battery latch is found to be detached and was not returned with the sample.Functional evaluation of the sample is done while pushing the battery pack into the housing and the device irrigated as intended.Sample evaluation finds the device failed to irrigate as a result of the detached battery latch.This allowed for the battery case to become loose within the handle resulting in the batteries not making complete contact with the electrical contacts inside of the handle.The detached battery latch is not indicative of the as manufactured condition.Based on the sample evaluation and the investigation performed, the root cause of the latch detaching is due inadvertent damage to the unit while in use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.Sample evaluated.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12806837
• Report Number: 1213643-2021-20411
• Device Sequence Number: 19999005
• Product Code: FQH
• UDI-Device Identifier: 00801741010125
• UDI-Public: (01)00801741010125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2021

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: 01/28/2024
• Device Catalogue Number: 0067570
• Device Lot Number: JUFP0411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown