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

Catalog Number UNKAA038

Device Problems Thermal Decomposition of Device (1071); Corroded (1131); Fluid/Blood Leak (1250); Device Emits Odor (1425)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the hydrosurg irrigator leaked water in the battery compartment.No additional information has been provided and the subject device has not been returned for evaluation.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.No lot number has been provided; therefore, a review of the manufacturing records is not possible.If/when sample is received and/or additional information is provided, a supplemental mdr will be submitted.

Event Description

The following was reported to bd by the fda via medwatch# (b)(4): "during robotic case the crna, rn and techs in the room noticed a burning/chemical smell coming from up at the head of the bed near the anesthesia machine.The pod leader was notified, and she came in and inspected the equipment.She called the front desk and let the biomed/engineering department know.Someone from that department came up and looked at the equipment and could not find anything either.The pod leader had a stryker representative come in and look at the neptune and they changed the filter on that just in case.The smell came in waves throughout the case and the biomed came up one more time to take a look.They suspected the anesthesia machine being the issue.The crna and anesthesiologist said they couldn't see anything on their end malfunctioning and the patient was safe.It was determined to finish the case and have the machine looked over in between cases.At the end of the case, we were cleaning up and took down the suction irrigator and one of the nurses said let look at that piece of equipment and we all smelled it and that was the source of the smell.We opened the part that contains the batteries and saw some fluid had entered that part and was corroding the batteries and the electrical smell was very strong.I asked the crna if she still wanted the machine looked at and she said no, and i followed up with biomed and let him know we did not need them to look at it as well.I took the pack sheet and the irrigator and have those placed in the drawer for equipment that has malfunctioned.".

Manufacturer Narrative

As reported, the hydrosurg irrigator leaked water in the battery compartment.No additional information has been provided and the subject device has not been returned for evaluation.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.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this is an addendum to the initial mdr submitted.This semdr is submitted to make a correction to the annex a coding.If/when sample is received and/or additional information is provided, a supplemental mdr will be submitted.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.

Event Description

The following was reported to bd by the fda via medwatch# (b)(4): "during robotic case the crna, rn and techs in the room noticed a burning/chemical smell coming from up at the head of the bed near the anesthesia machine.The pod leader was notified, and she came in and inspected the equipment.She called the front desk and let the biomed/engineering department know.Someone from that department came up and looked at the equipment and could not find anything either.The pod leader had a stryker representative come in and look at the neptune and they changed the filter on that just in case.The smell came in waves throughout the case and the biomed came up one more time to take a look.They suspected the anesthesia machine being the issue.The crna and anesthesiologist said they couldn't see anything on their end malfunctioning and the patient was safe.It was determined to finish the case and have the machine looked over in between cases.At the end of the case, we were cleaning up and took down the suction irrigator and one of the nurses said let look at that piece of equipment and we all smelled it and that was the source of the smell.We opened the part that contains the batteries and saw some fluid had entered that part and was corroding the batteries and the electrical smell was very strong.I asked the crna if she still wanted the machine looked at and she said no, and i followed up with biomed and let him know we did not need them to look at it as well.I took the pack sheet and the irrigator and have those placed in the drawer for equipment that has malfunctioned.".

• 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: 12850220
• MDR Text Key: 281067179
• Report Number: 1213643-2021-20429
• Device Sequence Number: 1
• Product Code: GCJ
• 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,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR
• Patient Sex: Male