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

Catalog Number	0067570
Medical Device Problem Codes	Break (1069); Inability to Irrigate (1337)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was received for evaluation, with the battery pack installed within the handle of the device.The latch tab used to secure the device¿s battery pack within the device handle was noted to be broken and the latch tab not returned with the device.Even with the broken latch tab, the battery pack was noted to remain fully seated and remained firmly within the handle.There was no report of the component breakage by the user, and it was indicated the user released the latch to remove the batteries and the latch on the bottom of the hand piece broke.Based on the information provided, the broken battery latch tab that was found during the product evaluation was related to the user removing the battery pack after the device failed to irrigate.While the cause of the original report of the non irrigating device has not been determined at this time, root cause of the broken latch has been determined to be use related.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
Information as reported by the user facility: during the sample evaluation of a simpulse solo irrigator reported as not irrigating, the latch on the battery case was found broken off and not returned.Additional information received from the sales rep indicated the user facility released the latch to remove the batteries and the latch on the bottom of the hand piece broke.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 6561803
• Report Number: 1213643-2017-00303
• Device Sequence Number: 627561
• Product Code: FQH
• UDI-Device Identifier: 00801741010125
• UDI-Public: (01)00801741010125(17)190228(10)JUAPF655
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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: 02/28/2019
• Device Catalogue Number: 0067570
• Device Lot Number: JUAPF655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1