MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR FIXEDPIN HEMOSTATIC PROBE

Model Number CD-B622LA

Device Problems Failure to Deliver Energy (1211); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.In addition, as stated in section event, follow up is in progress to gather additional information regarding the event reported.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported "the accessory (cd-b622la) serial # (b)(4) and serial # (b)(4) was placed, one of each serial number, and the bipolar part of the esg-100 in soft coag 30 but it did not burn.According to the reporter, the serial # (b)(4) was replaced by another serial # (b)(4).According to the report, the same device was not used to complete the procedure, noted the intended procedure was not completed, however, the report noted , the issue was noticed after procedure ( therapeutic esg endoscopy).A follow up is in progress to gather additional information regarding the reported event.There was no patient harm, no user injury reported due to the event.This event includes two reports: report with patient identifier (b)(6) serial # (b)(4).Report with patient identifier (b)(6) serial # (b)(4).This report is for report with patient identifier (b)(6), serial # (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response regarding the event reported, device evaluation and legal manufacturers investigation.Communication with the customer facility the following information conveyed: the device did not cauterized properly.According to the report, could not complete procedure, patient was referred to another institution.No other information provided.The subject device was received and evaluated.The customer returned a 7fr fixedpin hemostatic probe model number cd-b622la lot number kr197811 for the evaluation.A visual inspection on the as is received condition of the device performed; noted that the device was returned in its original packaging however opened and used.The sterile packaging has no signs of punctures or tears.The female luer was examined and was unable to identify any cracks or damages.The electrical connector as well has no signs of physical damage, as the pins appear to be in good condition.Performed testing by flushing port tubing as well as the rest of the tubing on the device and verified there were no kinks or excessive bends.The distal end was observed under a microscope and identified dried foreign residue on the hemostasis tip, which is consistent with usage.The width of the tip was measured with a test caliper and the measurement noted as 2.3 mm.Performed functional test using a test esg-100 electrosurgical generator along with a test foot switch model number wb950243.The esg-100 electrosurgical generator is running on software version 2.11-a.Testing performed, inserted the electrical connector of the customer¿s probe into the bipolar port of the esg-100.The electrical connector was able to securely stay inserted into the bipolar port with no issues of restriction or looseness.Testing ensured that the probe as well as the foot switch was connected before powering on the esg-100 generator.The power switch on the front panel was pressed and the esg-100 generator powered on with no issues.The esg-100 generator was set to soft coag, power level 30, placed the tip of the probe to a 1 ml-2ml drop of saline, the blue pedal on the foot switch was pressed and observed bubbling as well as sizzling indicating the device was working properly as power was being provided through the distal end tip, activated the probe several times while changing to different mode settings (rfcoag, rfcoag + rcap, soft coag) as well as adjusting different power settings observing output power being provided through the distal end as the saline was bubbling and sizzling.Based on the device evaluation, it is unable to determine the customer's issue of "esg-100 in soft coag 30 but it did not burn" as during testing, it was observed energy being provided through the tip for soft coag power level 30 as well as other modes and power settings.As the device functioned as intended, the initial complaint could not be confirmed.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." the device history records (dhr¿s) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Dhr review for this lot found no associated ncrs (nonconformance's), reported scrap or recorded process deviations relating to the reported failure.Olympus will continue to monitor complaints for this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Type of Device: HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15831894
• MDR Text Key: 305376390
• Report Number: 3005975494-2022-00064
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• Combination Product (y/n): N
• PMA/PMN Number: K123319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-B622LA
• Device Lot Number: KR197811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ESG-100