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

Catalog Number	0067570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, upon opening the package, the battery holder clip of the simpulse solo device was noted to have broken off at one end.There was no reported patient injury.The subject device was returned with the batteries removed, but not in its original packaging.Note, clip must be broken off to remove the batteries from the case.As the device was not returned in its original state and was manipulated / handled a definitive root cause could not be determined.The most probable root causes may be related to a manufacturing issue, damage in transit, or user interface/ handling the device prior to use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 1500 units released for distribution in (b)(6) 2022.Sample evaluated.
Event or Problem Description
As reported, during preparation for an ortho recon procedure on (b)(6) 2022, it was noted when bard/davol simpulse solo device removed from packaging the battery holder clip was broken off at one end.It was also reported that the device was switched out before the case begun.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
• 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: 15615081
• Report Number: 1213643-2022-00648
• Device Sequence Number: 5983311
• Product Code: FQH
• UDI-Device Identifier: 00801741010125
• UDI-Public: (01)00801741010125
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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: 02/28/2025
• Device Catalogue Number: 0067570
• Device Lot Number: JUGQ1522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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