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

Model Number	CD-B622LA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned for evaluation.Supplemental report(s) will be submitted should any relevant new information is available and or received.The investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, the gi physician used the bicoag hemostasis probe for gi bleeding in duodenal on (b)(6) 2022.During procedure (therapeutic), the doctor discovered the tip of probe was detached from its body.The device was replaced.The intended procedure was completed using similar device.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented based on customer response and updates.Communication with the customer conveyed that the subject device was discarded and will not be returned however, photo of the damage device with a detached unit was provided for evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation, possible causes may include the following: the observed failure is a known phenomenon likely resulting from using the device tip past its intended range of view or range of motion.A definitive root cause cannot be identified.This issue is covered in the instructions for use: 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 the field performance of this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Common Device Name: FIXEDPIN HEMOSTATIC 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: 14793757
• Report Number: 3011050570-2022-00080
• Device Sequence Number: 6107827
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022

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: CD-B622LA
• Device Lot Number: KR206292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 06/24/2022; 07/08/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/01/2022; 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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
• Patient Sex: Unknown