MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 NEZHAT-DORSEY SMOKEVAC IRRIGATION TUBING SET; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5202770
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the laparoscopic tip of the nezhat-dorsey smokevac irrigation tubing set broke during use.As reported, the subject device is not available for evaluation, however same lot samples (3) have been received.The irrigation and suction buttons on the trumpet valve were pressed and function as intended.The white caps are attached with no anomalies found.Based on the lot sample evaluation and investigation performed, a definitive root cause cannot be determined, however the most probable root cause is an event occurring during user device interface.Review of manufacturing records confirms product was manufactured to specification.This mdr represents the bard/davol nezhat-dorsey smokevac irrigation tubing set (device #3).Additional mdrs were submitted to represent the two bard/davol nezhat-dorsey smokevac irrigation tubing set (device #1 & device #2).Lot sample evaluated.
Event or Problem Description
As reported, during laparoscopic cholecystectomy procedure on (b)(6) 2022, three bard/davol nezhat-dorsey smokevac irrigation tubing sets were used with a manual bulb pressure bag system.As reported, the press attachment for the laparoscopic tip cracked/broke with initial irrigation flow on all three devices.As reported, the procedure was completed by using a reusable screw-in laparoscopic suction irrigation tip on final trumpet, with press fitting removed.There was no reported patient injury/harm.

• Brand Name: NEZHAT-DORSEY SMOKEVAC IRRIGATION TUBING SET
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 15835409
• Report Number: 1213643-2022-00757
• Device Sequence Number: 5762042
• Product Code: GCJ
• UDI-Device Identifier: 00801741065392
• UDI-Public: (01)00801741065392
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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: 09/28/2024
• Device Catalogue Number: 5202770
• Device Lot Number: JUFW1787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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