MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS STERNAL SAW SYSTEMS; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS

Model Number 15665

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the rn on (b)(6) 2015, the patient seemed to be doing great and was sitting up today.

Event Description

It was reported that during pre-cardiopulmonary bypass of the device for a cardiopulmonary bypass procedure, they could not connect to the motor right away.They finally got the flexible drive cable inserted.The end pieces were wobbly.The device was not changed out.There was a momentary delay, not clinically significant per the nurse (rn).She was just panicked since this was an emergency case.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient.Per clinical review on 22-oct-2015: prior to surgery, the connection of the sternal saw cable to the motor could not be connected in a timely matter.As this was an emergent case, it resulted in a momentary delay in the procedure, but per the rn not of any clinical significance.After the case, the rn brought in another motor and cable.She connected the new cable to the original motor and it connected properly.She tried the old cable with the new motor and had an issue with them connecting.Therefore; she felt as though it was an issue with the cable and not the motor.The case was completed successfully, with a momentary delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) performed a functional test and observed difficulty inserting the customer's flex cable into the service test motor.The srt performed an internal inspection and observed the inner core lacked lubrication.The srt replaced the inner core and performed verification / release testing.The flex cable operated to the manufacturer's specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS STERNAL SAW SYSTEMS
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL-SARNS STERNAL SAW SYSTEMS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5207098
• MDR Text Key: 30788256
• Report Number: 1828100-2015-00949
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15665
• Device Catalogue Number: 15665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1