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

Catalog Number	0067590
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	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the simpulse solo device stopped working halfway through the procedure.The subject device was returned for evaluation.During the sample evaluation the latch that retains the battery pack was detached and not returned with the device.How or when the latch became detached was not reported.Functional evaluation of the device returned was performed by connecting the unit to the lab iv bag filled with water.The returned sample was found to power up when the trigger was compressed and irrigate as intended.The reported event may be the result of the battery latch detaching and causing batteries to not be fully engaged presenting a no power condition.Review of manufacturing records confirms product was manufactured to specification.This emdr represents device #2, an additional emdr was submitted to represent device #1 for detachment of component.Sample evaluated.
Event or Problem Description
As reported, during orthopedics procedure on (b)(6) 2021 a bard/davol simpulse solo w/soft splash shield tip device was used.The device stopped working half way during procedure and new one was opened.It was reported that three bard/davol simpulse were opened and used on the same procedure and all the devices stopped working half way during procedure.As reported, the procedure was completed using another bard/davol simpulse device.There was no reported patient injury.

• 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
• MDR Report Key: 12315740
• Report Number: 1213643-2021-20245
• Device Sequence Number: 4585878
• Product Code: FQH
• UDI-Device Identifier: 00801741010132
• UDI-Public: (01)00801741010132
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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: 12/28/2023
• Device Catalogue Number: 0067590
• Device Lot Number: JUEZ1495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other