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

Model Number CD-B622LA

Device Problem Insufficient Heating (1287)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned.Per the customer, it is unknown if the device will be returned back for evaluation since it is in the bio-hazard container and may have been thrown out.Subsequently, the customer has been unresponsive to requests for follow up.For this reason a definitive root cause could not be determined.If the device, or additional information, becomes available at a later date the complaint will be updated accordingly.Based upon review of production records there appears to be no indication that manufacturing contributed to the reported failure as all devices met final acceptance criteria prior to release.Olympus will continue to monitor complaints for this device through regular trending activities as defined by olympus surgical technologies america quality management system procedure.

Event Description

It was reported during an emergent procedure while attempting to cauterize an gastrointestinal arteriovenous malformation (avm), the probe did not heat up.As a result, there was a delay in cauterizing the avm.The clinician was required to use a hot snare to cauterize the avm and complete the procedure.Other than the delay in the procedure, no other patient impact occurred.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Type of Device: HEMOSTASIS PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 9013785969
• MDR Report Key: 10468659
• MDR Text Key: 204985022
• Report Number: 3005975494-2020-00019
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-B622LA
• Device Lot Number: KR869055
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention