MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number HAR36

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use and an indentation in the teflon pad was identified.The blade, jaw, teflon pad and contact rings appear to be intact.Functional inspection revealed the device successfully cut and coagulate without producing an error code nor emitting any adverse noise while the jaws were open.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore, the most likely root causes are: - ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor) - applying improper or inadequate directional and/or rotational force to connect instrument to hand piece.The instructions for use (ifu) state: - the instruments allow for the coagulation of vessels up to and including 5 mm in diameter.Do not attempt to seal vessels in excess of 5 mm in diameter.- care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that during use, two errors to release pressure occurred with harmonic scalpel (har36).The device would 'buzz' with tissue contact and another error would come up to release pressure.The same issue occurred with six devices used in this case.In total, 400cc of blood was lost in the laparoscopically assisted vaginal hysterectomy (lavh) and 200cc was lost in the bilateral tubal ligation (btl).No transfusion was required.A tube and ovary were removed due to being unable to make the devices work properly.In total, the procedure was delayed 30 minutes in the lavh and 20 minutes in the btl.The device was replaced.The patient's condition was stable post-procedure.These are commonly used devices that are readily available.

• Brand Name: NA
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: marissa richmond ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 7140446
• MDR Text Key: 95594011
• Report Number: 0001056128-2017-00144
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)181030(10)7394998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 7394998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1