MAUDE Adverse Event Report: GYRUS ACMI, INC. 10FR FIXEDPIN HEMOSTATIC PROBE

Model Number CD-B612LA

Device Problems Break (1069); Fracture (1260)

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

Event Date 03/25/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported the device was used for a case (an unspecified procedure) and during the procedure, the sheath of bicoag probe was fractured around the site of duodenum before the user apply the heat energy.There was no adverse event reported.No harm or injury to patient was reported.No user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on response to follow up.Communication with the customer via company representative conveyed the following information: two cd-b612la devices failed in the same procedure.The failures were reported under patient identifier c23157666 (lot kr206276) and patient identifier (b)(6) (lot kr200145).The procedure was a therapeutic upper gastrointestinal (gi) endoscopy.The intended procedure was completed with a third device (same model, different lot).No fragments fell into the patient's body.It is unknown whether there was any delay in the procedure.There was no medical intervention.The reported failures did not affect the outcome of the procedure.This supplemental report is for patient identifier (b)(6) (lot kr200145).Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

The initial medwatch incorrectly reported the site registration number.The site registration number is (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's final investigation.Please also refer to h4 for manufacturing date updates.The device manufacturing date is being corrected from march 5, 2022 of the initial mdr report.The correct manufacturing date is feb 10, 2022.The returned device was inspected, and the complaint was confirmed.The device was returned in its original packaging.The model was confirmed to be cd-b612la and lot was kr200145.Upon inspection, it was observed that the probe sheath above the hemostasis tip was broken but not completely detached, and the internal wires remained intact.The presence of blood residue on the sheath, on the probe tip, and inside the luer, indicated prior usage.No other damages were observed besides the broken tip.To test functionality, the device was connected to a bipolar generator, and the tip was submerged in a small amount of saline.The application of energy resulted in bubbling of the saline, indicating proper energy transmission.Due to the broken tip, testing of irrigation capability was not possible.In summary, the device functioned as intended, however, the probe sheath above the hemostasis tip was broken.Review of device history record (dhr) records provided no indication that manufacturing procedures contributed to the reported event.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on inspection findings, the observed sheath fracture may have resulted from the probe being buckled and bound inside the scope's channel with excessive force or the distal probe tip being subjected to blunt force against a hard object.However, the exact cause could not be definitively determined during the investigation.Page 6 of the device ifu (instructions for use_p9100505-001_ah) addresses this: "do not use the device if resistance to insertion is encountered.Reduce the angle or lower the forceps elevator of the endoscope until the device passes smoothly; do not advance or extend the device abruptly; insert the device slowly.Abrupt insertion may cause damage to the endoscope or the device." in addition, page 3 of the ifu states ¿keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury." olympus will continue to monitor complaints for this device.

• Brand Name: 10FR 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: 16777425
• MDR Text Key: 313663565
• Report Number: 3005975494-2023-00078
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00821925039476
• UDI-Public: 00821925039476
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K123319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2023

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
• Device Operator: Health Professional
• Device Model Number: CD-B612LA
• Device Lot Number: KR200145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 04/21/2023; 05/01/2023; 05/24/2023
• Supplement Dates FDA Received: 05/15/2023; 05/18/2023; 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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