MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. HYDROSURG IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0026870

Device Problems Material Fragmentation (1261); Premature Activation (1484); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the sample and information provided by the customer confirms prematurely activation.The isolator switch moved to the on position in the package.The motor running without fluid in the system resulting in material debris being present in the pump head.When functionally tested with fluid by the customer the debris entered the fluid path, as reported.The premature activation that caused the switch to move to the on position presented during transit/handling after manufacture.A review of the manufacturing records was performed and found that the lot was manufactured to specification.A review of the subject lot found this to be the first complaint reported for the 1440 units released to stock in (b)(6) 2018.

Event Description

It was reported that a hydrosurg suction irrigator was found turned on while still in the sterile packaging.Due to the motor running prematurely prior to use inside the packaging, there appeared to be small fragments that had detached.This was confirmed by the customer by performing a simulated use.When the hydrosurg was connected to saline and rub they noted debris material in the fluid path.The unit was retuned for evaluation.The unit was not used to treat a patient.

• Brand Name: HYDROSURG IRRIGATOR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 8233796
• MDR Text Key: 132635281
• Report Number: 1213643-2019-00162
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362(17)210528(10)JUCTF013
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/09/2019

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: 05/28/2021
• Device Catalogue Number: 0026870
• Device Lot Number: JUCTF013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2018
• 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