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	Break (1069)
Health Effect - Clinical Codes	Burn(s) (1757); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Upon follow up for patient identifier (b)(6) involving a patient burned when subject device sparked, the customer reported a second event.During the week of (b)(6) 2022, the subject device fell apart in the patient and all pieces were retrieved.The customer refused to provide additional information and stated the event was submitted via medsun report.
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.

• 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 ; 2400 ringwood avenue; san jose, CA 95131 ; 4848965250
• MDR Report Key: 14877708
• Report Number: 2951238-2022-00448
• Device Sequence Number: 5073860
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2022

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: FR163690
• 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: 06/01/2022
• Initial Report FDA Received Date: 06/30/2022
• Date Device Manufactured: 07/22/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown