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

Catalog Number 0026870

Device Problems Thermal Decomposition of Device (1071); Corroded (1131); Fluid/Blood Leak (1250); Smoking (1585); Electrical Shorting (2926)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the operating room staff smelled smoke during a case and corrosion of battery was noted inside the battery compartment of the bard/davol hydro-surg irrigator.As reported, the subject device is being returned for evaluation; however at this time it has not been received.Based on the condition reported, the root cause is most probably due to fluid ingress into the unit housing.However, without sample evaluation, a definitive conclusion cannot be made.Note, the date of event is considered to be a best estimate as (b)(6) 2021 based on the reported event.If/when the sample is returned and evaluated, a supplemental mdr will be submitted.

Event Description

As reported, during use of a bard/davol hydro-surg laparoscopic irrigator, the operating room staff smelled smoke.As reported, the length of device use is unknown and no fire or smoke was noted.The device was removed from the operating room and another hydro-surg was used to complete the case.It was reported that the device was provided to the biomed department and battery corrosion was noted inside the battery compartment.As reported, there were no parts of the device that appeared to be melted.

Event Description

As reported, during use of a bard/davol hydrosurg laparoscopic irrigator, the or staff smelled smoke.As reported, the length of device use is unknown and no fire or smoke was noted.The device was removed from the or and another hydrosurg was used to complete the case.It was reported that the device was provided to the biomed department and battery corrosion was noted inside the battery compartment.As reported, there were no parts of the device that appeared to be melted.

Manufacturer Narrative

As reported, the or staff smelled smoke during a case and corrosion of battery was noted inside the battery compartment of the bard/davol hydrosurg irrigator.As reported, the subject device is being returned for evaluation; however at this time it has not been received.Based on the condition reported, the root cause is most probably due to fluid ingress into the unit housing.However, without sample evaluation, a definitive conclusion cannot be made.Note, the date of event is considered to be a best estimate as (b)(6) 2021 based on the reported event.Addendum: this is an addendum to the initial mdr submitted to document the results of sample evaluation.Visual examination identifies that an electrical short circuit presented during use causing the melting/charring of internal components.Evaluation of the sample finds that the there is evidence of fluid ingress into the battery compartment.Sample evaluation finds fluid leaked into the battery compartment resulting in a thermal event.Cracks and excessive rtv were identified on the motor mount and impeller allowing fluid to pass through the motor mount and down the sides of the motor to the pc board and battery compartment.Based on our evaluation and condition of the device, the root cause is determined to be manufacturing related.Note: section a through f - the information provided by bd 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 bd.H3 other text : sample evaluated.

• 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
• MDR Report Key: 12642793
• MDR Text Key: 276823236
• Report Number: 1213643-2021-20364
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362
• Combination Product (y/n): N
• PMA/PMN Number: K961492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other,user facili
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• 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: 0026870
• Device Lot Number: JUFR0573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other