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  

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) ( cd-b622la serial #(b)(4).

Manufacturer Narrative

The subject device was not returned for evaluation.As stated in event section, 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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response regarding the event reported.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.Device is not returning as it was discarded.No other information provided.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h4, h6, and h10.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.It has been over 2 years since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.Olympus will continue to monitor field performance 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 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: 15831838
• MDR Text Key: 305374016
• Report Number: 3005975494-2022-00063
• 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,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: KR914849
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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