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

Model Number HARH45

Device Problem Energy Output Problem (1431)

Patient Problem Blood Loss (2597)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The blade was identified to be fractured and detached from the device.The teflon pad and contact ring appear to be intact, however the jaw was detached from the actuating shaft.The blade was examined further revealing signs of coating removal near the break as a result of activating against solid/hard materials.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 or plastic.The instructions for use (ifu) state: use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.Do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.Avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.Note: do not use any other means than 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.The reported event will continue to be monitored through post-market surveillance.

Event Description

During a bariatric case, it was reported a piece of blade fell off the harmonic scalpel (harh45) into the patient.The piece was retrieved without requiring x-ray nor open procedure.The device was replaced.The patient then came back into surgery due to internal bleeding an hour or two later.The patient was brought back for two separate open procedures after the original procedure, approximately 7 liters of blood were lost according to anesthesia.The patient received multiple transfusions.It is unknown by the facility contact if there will be additional follow-up.These are commonly used devices that are readily available.

Manufacturer Narrative

Corrected data received from the customer after the initial mdr was filed was added to the executive summary.This information does not change the type of reportable event.

Event Description

During a bariatric case, it was reported a piece of blade fell off the harmonic scalpel (harh45) into the patient.The piece was retrieved without requiring x-ray nor open procedure.The facility contact is not aware of a replacement device being used.The patient then came back into surgery due to internal bleeding an hour or two later.The patient was brought back for two separate open procedures after the original procedure, approximately 7 liters of blood were lost according to anesthesia.The patient received multiple transfusions.It is unknown by the facility contact if there will be additional follow-up.These are commonly used devices that are readily available.

Manufacturer Narrative

On 11/18/2020, stryker sustainability solutions became aware that mdr section b2.(outcomes attributed to ae) was not completed for this mdr.This supplemental mdr serves to provide this information.The reported event will continue to be monitored through post market surveillance.

Event Description

During a bariatric case, it was reported a piece of blade fell off the harmonic scalpel (harh45) into the patient.The piece was retrieved without requiring x-ray nor open procedure.The facility contact is not aware of a replacement device being used.The patient then came back into surgery due to internal bleeding an hour or two later.The patient was brought back for two separate open procedures after the original procedure, approximately 7 liters of blood were lost according to anesthesia.The patient received multiple transfusions.It is unknown by the facility contact if there will be additional follow-up.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; 5300 region ct; lakeland FL 33815
• MDR Report Key: 8553221
• MDR Text Key: 143248512
• Report Number: 0001056128-2019-00024
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 07613327346244
• UDI-Public: 07613327346244
• Combination Product (y/n): N
• PMA/PMN Number: K161693
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Model Number: HARH45
• Device Catalogue Number: HARH45RR
• Device Lot Number: 9530981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/26/2019; 11/18/2020
• Supplement Dates FDA Received: 04/29/2019; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention