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

Model Number CD-B622LA

Device Problem No Device Output (1435)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during an unspecified procedure the device bicoagulation probe did not work at all to coagulate a gi bleed on the patient.The user opened another probe to coagulate the gi bleed in the patient.The lot number used was not provided.The reporter stated that the event did not delay the procedure much.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d9,g3, g6, h2,h3, h4, h6 and h10.The returned device was received and evaluated.Inspection found the device did have dried blood that wrapped around the distal end of the probe.The blood seemed to be only covering part of the gold electrode tip.The device distal tip was cleaned to remove any of that dried blood before testing the functionality of the probe.The device was plugged into a generator and tested for coagulation.Using a piece of meat, the coagulation feature was able to heat up and coagulate the meat.There was a kink in the wiring, however, upon opening up the wire to see if there was any damage, it was observed that there was no damage to the actual wiring itself.Since the device was able to heat up and coagulate, the initial complaint cannot be confirmed.The observed failure is a known phenomenon resulting from an insufficient level of coagulation.Page 6 of the device ifu (instruction for use) (p9100505-001_ah) addresses this: "insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation".Olympus will continue to monitor the field performance of this device.

• Brand Name: 7FR FIXEDPIN HEMOSTATIC PROBE
• Type of Device: 7FR FIXEDPIN HEMOSTATIC PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11574606
• MDR Text Key: 243676693
• Report Number: 3011050570-2021-00058
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00821925039452
• UDI-Public: 00821925039452
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD-B622LA
• Device Catalogue Number: CD-B622LA
• Device Lot Number: KR936596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1