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U.S. Department of Health and Human Services

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

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COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
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.
 
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Brand NameCYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
Type of DeviceKNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key11928489
MDR Text Key281411905
Report Number3001845648-2021-00429
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K022595
Number of Events Reported1
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 Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCST-10
Device Lot NumberC1753330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/29/2021
Event Location Hospital
Date Manufacturer Received05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No

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