MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 DAVOL ADVANTAGE ELECTROSURGICAL ATTACHMENTS; LAPAROSCOPIC PUMP SYSTEM

Catalog Number	0043950
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the water leaked from the tube of probe between the endo-flo and the handle, prior to use on the patient.The subject device was returned for evaluation.Visual inspection showed that the device was in good condition with no damage found.During sample evaluation, it was noted that no fluid leak was identified from the trumpet valve body, tubing or luer lock connection.Evaluation of the sample could not reproduce the reported event.The trumpet valve & probe tip was found to irrigate as intended with no fluid leaks identified.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed this complaint is unconfirmed for the reported event.It is unclear why the user may have experienced a water leak.The use of this device requires proper set up.Per the instructions-for-use, ¿follow instructions provided with the endo-flo irrigator or other irrigation system of choice for set-up and use with the probe.¿ a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units release in december, 2019.Sample evaluated.
Event or Problem Description
As reported, while using the endo-flo irrigator with trumpet valve & probe tip device on (b)(6) 2020, water leaked from the tube of the probe, between the endo-flo and the handle, prior to use on the patient.There was no reported patient or user injury.The surgeon used another device to complete the procedure.

• Brand Name: DAVOL ADVANTAGE ELECTROSURGICAL ATTACHMENTS
• Common Device Name: LAPAROSCOPIC PUMP SYSTEM
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10613667
• Report Number: 1213643-2020-20008
• Device Sequence Number: 2554943
• Product Code: HET
• UDI-Device Identifier: 00801741065231
• UDI-Public: (01)00801741065231
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K941334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 10/28/2021
• Device Catalogue Number: 0043950
• Device Lot Number: JUDY0301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 10/01/2020
• 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