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

Model Number HAR36

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection, an indentation in the teflon pad and evidence of clinical use including tissue build up was identified.The device was disassembled to inspect the blade rod and distal gasket.The distal gasket appeared to be intact.The blade was cleaned then inspected and a fracture near gouges was found on the distal blade.There were signs of gouging on the blade as a result of activating against a solid surface.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: - jaws/blade subassembly damage.- incidental and prolonged activation against solid surfaces, such as bone, metal or plastic.The instructions for use (ifu) state: - avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.- use the torque wrench (already mounted to the shaft) to tighten the blade on the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating the sufficient torque has been applied to secure the blade.Note: do not use any other means that the torque wrench to attach or detach the instrument from the hand piece.Note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.Note: hold only the gray hand piece and not the instrument handle while applying the torque wrench.- close the trigger remove the torque wrench by sliding it off of the shaft.Do not dispose of the torque wrench until the procedure is completed.The torque wrench is used to remove the instrument from the hand piece following the procedure.Dispose the torque wrench only after completing the procedure.Note: take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft.Note: take care to avoid injury from the blade tip while sliding the torque wrench onto or off of the shaft.-for optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.Note: do not touch the instrument to metal while activated.Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.-if tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged.The reported event will continue to be monitored through post-market surveillance.

Event Description

It was reported that the machine stated to relax pressure when nothing was being held in the device jaws.A new hand piece had to be obtained and reconnected, leading to a delay of 30 minutes.No additional sedation was required.There was no patient injury or medical intervention reported.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: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 6330194
• MDR Text Key: 67607652
• Report Number: 0001056128-2017-00028
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)171114(10)5124617
• 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: 02/14/2017

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: 11/14/2017
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 5124617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2016
• 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