MAUDE Adverse Event Report: GYRUS ACMI, INC 7FR COAX HEMOSTATIC PROBE; CD-B620LA

Model Number	CD-B620LA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.This report will be supplemented accordingly following investigations.
Event or Problem Description
The tip broke off when the cd-b60la was inserted into the scope.The issue occurred in the middle of a colonoscopy procedure.The intended procedure was completed using another probe.There was no delay in the procedure, and the customer did not report any health consequence to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The returned device was evaluated.Inspection noted that the coaxial model electrical connector was present and without any physical damage.The female luer was in good condition and had no physical damage.The main sheath did not have physical damage.The hemostasis tip was in good condition, without any physical damage.There was some visible dried blood that was on the hemostasis tip.The sheath was fractured near the proximal end of the probe, approximately 0.4375 inches from the proximal hemostasis tip.The section of the sheath with the hemostasis tip was completely separated from the main body of the sheath.The electrical wiring within the sheath was still connected.Functional test was performed using the coagulation features, the device was confirmed to be able to heat up on command.This also confirms the electrical wiring system remained intact.Based on the event description of the tip breaking off when being inserted in the scope, the complaint can likely be confirmed.Review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The observed failure is a known phenomenon resulting from forcing the device through resistance.As stated on the ifu (instruction for use) the user manual states: 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.Olympus will continue to monitor complaints for this device.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Common Device Name: CD-B620LA
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11640611
• Report Number: 3011050570-2021-00061
• Device Sequence Number: 16893899
• Product Code: KNS
• UDI-Device Identifier: 00821925039483
• UDI-Public: 00821925039483
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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-B620LA
• Device Lot Number: KR878933
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE.