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

Model Number CD-B612LA

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

No device returned to olympus for evaluation.The cause of the reported event cannot be confirmed.However, based on similar reported complaints, unintended operational error cannot be ruled out as a contributing factor of the reported event.To mitigate the risk of damage to the device the instruction manual cautions, ¿insert the device slowly.Abrupt insertion may cause damage to the endoscope or the device.¿.

Event Description

Olympus was informed that during hemostasis of a bleeding site in the patient¿s stomach, the physician was attempting to remove the probe out of the patient for cleansing when the probe reportedly broke off and fell into the stomach.The broken probe was retrieved from the patient using a grasping forceps.The intended procedure was completed using a different device, heatprobe.The procedure was delayed by 10 minutes.The patient did not require a longer stay or additional treatment.There are no reported issues with the patient.The device was used with reasonable insertion / pulling force.The scope used during the cases was a gif-2t240, the console was a erbe vio300d and was set to bipolar softcoag mode 25w effect 1.There was no reported issue with the other devices and there was no metal to metal contact reported.The device has been discarded following the procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide the device product code.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the dhr review performed.Based on the dhr review the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• Brand Name: 10FR FIXEDPIN HEMOSTATIC PROBE
• Type of Device: HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8122818
• MDR Text Key: 129344042
• Report Number: 2951238-2018-00732
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K123319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-B612LA
• Device Catalogue Number: CD-B612LA
• Device Lot Number: MK669752
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSOLE: ERBE VIO300D; OLYMPUS SCOPE, GIF-2T240, SN UNK.