MAUDE Adverse Event Report: MISONIX INC. MISONIX BONE SCALPEL TUBING SET MXB-T; INSTRUMENT, UNTRASONIC SURGICAL ASPIRATOR, ACCESSORY TUBING SET

Model Number MXB-T

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

The report indicated that the irrigation tubing set mxb-t for the bonescalpel ultrasonic surgical device was properly installed, yet it would not work properly.There for as hole found on the reinforced portion of the tubing.The device history record for the subject lot d141403 was reviewed.The inspection records did not indicate all samples were in conformance with specifications.No holes in the reinforced portion of the tubing were seen.Trend analysis indicates that there were no other complaints for holes on the tubing on the subject lot.The trend analysis indicates there was one other report of a hole in the tubing on a different lot from november 12, 2014 to november 12, 2015.(b)(4) mxb-t tubing sets were sold during this time period.If the tubing is not installed properly, the tubing may be pinched or otherwise not installed properly, the pump will not work properly and can damage the tubing.The tubing may jam the pump or the rollers my pinch and create a hole in the tubing.As stated by the reporter, the tubing set was installed into the peristaltic pump head; however, the bonescalpel would not operate.The instructions for use included the following illustrated cautions: caution 7.4 do not place the soft silicone tube behind or in front of the rollers (latch removed in illustrations).Caution 7.5 do not pinch the soft silicone tube when the latch is locked.Apply slight pressure to ensure that tubing rests within both v-notches.Close pump cover close the latch of the irrigation pump until it locks.Aution 7.6 do not pinch barb fittings when closing the latch.Caution 7.7 prime the irrigation tubing prior to use.At all times ensure that the irrigant flows towards the handpiece when footswitch is depressed.If no irrigant is flowing, cease use until flow is restored.Therefore, we conclude that this event was possibly caused by user error in not following installation instructions for the tubing set properly.Risk analysis of this event does not conclude there is a potential to cause serious injury or death.The set is sterile.The irrigation fluid is sterile.The irrigation tubing set is opened in the operating room.The surgical nurse preparing the system for surgery follows universal precautions to maintain sterility of the surgical field, including wearing sterile gloves.Therefore, breach of sterile fluid path is not probable.Breach of sterile surgical field is not probable.The event was detectable.The equipment did not operate.The tubing set was removed and a new tugging set installed.Additional tubing sets are readily available in the surgical suite.Therefore, the risk of delay in treatment is not probable.Our instructions for use include the following warning: warning 1.2 the bonescalpel system is intended to be used in various types of invasive, surgical procedures.There may be indirect danger to the patient should the device fail during the procedure.It is recommended that the facility follows its back-up equipment protocols.

Event Description

Misonix irrigation tubset was properly connected to the misonix bonescalpel machine and primed.When surgeon attempted to begin using the bone scalpel, it would not work properly and there was found o be a hole in the reinforced portion of the tubing.The gaulty tubing wss removed from the bone scalpel and was given to materials management, who in turn contacted the vendor and returned product for evaluation.Device usage problem: not known.

• Brand Name: MISONIX BONE SCALPEL TUBING SET MXB-T
• Type of Device: INSTRUMENT, UNTRASONIC SURGICAL ASPIRATOR, ACCESSORY TUBING SET
• Manufacturer (Section D): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• Manufacturer (Section G): MISONIX INC.; 1938 new highway; farmingdale NY 11735
• Manufacturer Contact: john salerno ; 1938 new highway; farmingdale, NY 11735 ; 6319279123
• MDR Report Key: 5266152
• MDR Text Key: 32868088
• Report Number: 2435119-2015-00005
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2017
• Device Model Number: MXB-T
• Device Catalogue Number: MXB -T
• Device Lot Number: D141403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other