MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number CST-10

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/29/2021

Event Type  malfunction  

Event Description

Under eus control, echo-19 was inserted into the cyst, a awg2 wireguide was inserted through the needle into the cyst, the cst-10 was inserted along the awg2. The erbe vio3 was connected and inner catheter made hole in the cyst, then after switching the wire outer catheter made bigger hole in the cyst. While ejecting cst-10 from the working channel it turned out that the outer ring was left inside the working channel of the scope. It was necessary to remove the scope from the patient with the wireguide from the cyst. Then oa-10 was used to remove the outer ring from the working channel of the scope. Rep update ( 03/06/2021) under eus control, echo-19 was inserted into the cyst, a awg2 wireguide was inserted through the needle into the cyst, then inner catheter from cst-10 was removed and the cst-10 was inserted along the awg2. The erbe vio3 was connected and outer catheter made bigger hole in the cyst. While ejecting cst-10 from the working channel it turned out that the outer ring was left inside the working channel of the scope. It was necessary to remove the scope from the patient with the wireguide from the cyst. Then oa-10 was used to remove the outer ring from the working channel of the scope. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

The investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11928489
• MDR Text Key: 281411905
• Report Number: 3001845648-2021-00429
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K022595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CST-10
• Device Lot Number: C1753330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2021
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No