MAUDE Adverse Event Report: GYRUS ACMI, INC. 33 CM PKS PLASMASPATULA W/CORD (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	952005PK
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus received the following event from an olympus sales specialist.During an unspecified procedure, the device sparked and caused an unspecified patient burn when the user hit the plastic code during insertion with the device.The user reported this occurred when the spatula was being pulled out of the patient and the burn went through the drape to the patient.The customer refuses to provide additional information and stated this was user error.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.New information added to the following fields: h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the device coming in contact with other instruments/components in addition to being activated.The instructions for use warn against this event: "do not insert or withdraw the instrument from the procedure site while power is activated.Do not activate the instrument while any portion of the tip is within the laparoscope working channel or the cannula.Carefully insert and withdraw the instrument to avoid possible instrument damage and/or injury to the patient or surgical personnel.".

• Brand Name: 33 CM PKS PLASMASPATULA W/CORD (5/PK)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave. north; brooklyn park MN 55445
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14604127
• Report Number: 3011050570-2022-00071
• Device Sequence Number: 12304389
• Product Code: GEI
• UDI-Device Identifier: 00821925036253
• UDI-Public: 00821925036253
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K041633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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 Model Number: 952005PK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN GENERATOR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown