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

Model Number CD-B620LA

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that after an ercp (endoscopic retrograde cholangiopancreatography) and papillotomia procedure, the doctor found out the device has left some parts from the coagulation tip inside the patients¿ duodenum.The device was used to coagulate bleeding from papilla.The procedure was completed without problems, the bleeding was stopped.The part was not removed from the patient and was left in the intestinal tract.The user/operator assumed that the parts of the device that were left inside the patient will come out along with a natural excrement.There was no patient impact or harm was reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).The dhr for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Upon evaluation of the returned device, the complaint was confirmed.The ceramic distal tip has detached from the device.Per customer report, the distal tip was not removed from the patient and will not be returned olympus.The tip was left in the colon to be passed naturally.A definitive root cause could not be determined however dhr records indicate the tip bonding and cure procedure was completed per specification therefore tip breakage was likely a result of blunt force impact during use.Olympus will continue to monitor complaints for this device.

• Brand Name: 7FR COAX HEMOSTATIC PROBE
• Type of Device: GYRUS ACMI BICOAG HEMOSTASIS PROBE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10401576
• MDR Text Key: 219547832
• Report Number: 3011050570-2020-00041
• 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
• Report Date: 10/20/2020

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
• Device Operator: No Information
• Device Expiration Date: 08/26/2022
• Device Model Number: CD-B620LA
• Device Lot Number: KR869935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR