MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0026880

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

The subject product was returned for evaluation and confirmed the reported condition of a missing component.Based on the condition of the sample this is identified as an out of the box condition.The customer reported the cap was not within the sterile package.Based on the sample evaluation the complaint is confirmed as a manufacturing error.Review of the device history records identified no anomalies in production of this lot of (b)(4) units.Release in june 2021.No other complaints have been reported to date for this lot.

Event Description

As reported, during a laparoscopic cholecystectomy procedure on (b)(6) 2021, the bard/davol hydrosurg plus laparoscopic irrigator device was presented for use.It was identified that the threaded cap on the nd handle was missing.The product packaging is reported as being completely sealed prior to opening for the case and noting the missing component.As reported, there was no prolongation of surgery time and another device was used to complete the procedure.There was no reported patient injury.Attempted use of the device with the cap missing would result in fluid leak.

• Brand Name: HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR
• Type of Device: 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: 12830603
• MDR Text Key: 280942539
• Report Number: 1213643-2021-20425
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741010224
• UDI-Public: (01)00801741010224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 0026880
• Device Lot Number: JUFR2878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other