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

Model Number	HARH45
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The blade, jaw, teflon pad and contact rings appear to be intact.It was observed that the blade was not aligned with the teflon pad.The external shaft appears to be bent.The device was disassembled and inspected for cracks under a microscope.The blade coating revealed signs of erosion near a blade fracture as a result of activating against solid/hard materials.Shaft pin was found to be slightly bent.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 or Problem Description
During a bariatric case, it was reported the harmonic scalpel (harh45) gave a "high pressure" reading on the generator.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.
Additional Manufacturer Narrative
On (b)(6) 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 or Problem Description
During a bariatric case, it was reported the harmonic scalpel (harh45) gave a "high pressure" reading on the generator.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.
Event or Problem Description
During a bariatric case, it was reported the harmonic scalpel (harh45) gave a "high pressure" reading on the generator.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.
Additional Manufacturer Narrative
A review of mdrs filed between april 25th, 2019, and august 19th, 2022, was conducted.Since april 25th, 2019, there have been no additional reports of serious injury or surgical intervention to preclude serious injury or permanent impairment related to this specific failure mode.Based on the analysis of mdr data compared to the firm¿s sales figures, the likelihood of this specific failure mode causing or contributing to another serious injury should the malfunction occur is considered negligible.As such, we will no longer be reporting for the failure mode in which an ultrasonic scalpel is confirmed for a blade not aligned with the teflon pad, a bent external shaft, a blade crack/fracture, and a bent shaft pin.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• Manufacturer Contact: andy dobos ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 8553239
• Report Number: 0001056128-2019-00025
• Device Sequence Number: 16243406
• Product Code: NLQ
• UDI-Device Identifier: 07613327346244
• UDI-Public: 07613327346244
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: HARH45
• Device Catalogue Number: HARH45RR
• Device Lot Number: 9352677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 11/18/2020; 08/19/2022
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 12/04/2020; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown