MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR COAX HEMOSTATIC PROBE; ELECTROSURGICAL PROBE

Model Number	CD-B620LA
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/19/2022
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
The customer informed olympus, during a therapeutic gastroscopy for gastrointestinal bleeding, the probe did not have any current output.Three (3) unknown clips were required to stop the bleeding.The procedure was completed with a similar device.The esg-100 was tested 21feb2022 by medical engineering and no issues were found.Facility tested training probe and no issues were found.The facility is comfortable using the probe and esg-100.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is undetermined.As stated in the instructions for use, this event could have been prevented: on page 6 of the device ifu (p9100505-001_ah), it states: "insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation" on page 3, it also states: "interference produced by the operation of high frequency surgical equipment may influence the operation of other electrical equipment adversely.".
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.
Event or Problem Description
Additional information received from the author: the author reported the bleeding was mild and was treated endoscopically.The patient did not require a transfusion or change in treatment course.The customer stated it is standard practice to use clips to stop gastrointestinal bleeds and the use of multiple clips is also standard.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Common Device Name: ELECTROSURGICAL PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 13869928
• Report Number: 3011050570-2022-00028
• Device Sequence Number: 11935055
• Product Code: KNS
• UDI-Device Identifier: 00821925039483
• UDI-Public: 00821925039483
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2022

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: CD-B620LA
• Device Lot Number: KR872267
• 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: 02/22/2022
• Supplement Date Received by Manufacturer: 03/28/2022; 06/17/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/25/2022; 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• 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: ESG-100 SERIAL (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown