MAUDE Adverse Event Report: GYRUS ACMI, INC.- OEM- MACRO-FCP,5MM/33CM (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	3600PK
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus received a medwatch report mw5110616 reported that the bipolar macro forceps worked only very minimally and did not coagulate as needed.Reporter noted on the form "output below specifications.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
The subject device was not returned for evaluation.The cause of the issue is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response and updates.Further communication with the customer, the following information conveyed: procedure performed was a diagnostic laparoscopy, left ovarian cystectomy, evacuation of hemoperitoneum.The procedure was able to be completed with another device (unknown model and serial number).Event did not have any effect on patient.A stated by the reporter, "no obvious affect immediately noted".Investigation is ongoing.This report will be supplemented accordingly following investigation.

• Brand Name: MACRO-FCP,5MM/33CM (5/PK)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.- OEM-; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15105366
• Report Number: 3005975494-2022-00020
• Device Sequence Number: 4213958
• Product Code: GEI
• UDI-Device Identifier: 00821925036093
• UDI-Public: 00821925036093
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K031078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 3600PK
• Device Lot Number: FR207463
• 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: 06/28/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown