CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
Report
- Report Number
- 3001845648-2024-00502
- Event Type
- Malfunction
- Date Received
- August 21, 2024
- Date of Event
- July 5, 2022
- Report Date
- July 29, 2025
- Manufacturer
- COOK IRELAND LTD
- Product Code
- KNS
- PMA / PMN Number
- K022595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
DEVICE EVALUATION THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE, "THE ROLE OF ANTIBIOTICS IN ENDOSCOPIC TRANSMURAL DRAINAGE OF POSTINFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS" THE DEVICE EVALUATION COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. ABNORMAL USE COMPLAINTS ARE CONSIDERED TO BE BEYOND ANY FURTHER REASONABLE MEANS OF INTERFACE-RELATED RISK CONTROL BY THE MANUFACTURER. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. IT SHOULD BE NOTED THAT THIS FILE IS RELATED TO ANOTHER COMPLAINTS FILE. FOR DETAILS OF THE OTHER INVESTIGATION PLEASE REFER TO PRS: 438164, 438183, 438184, 438695, 439272, 439274 AND 439276. MANUFACTURING RECORDS PRIOR TO DISTRIBUTION, ALL CST-10 DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. AS THE LOT NUMBER IS UNKNOWN A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. INSTRUCTIONS FOR USE AND/LABEL AS PER THE INSTRUCTIONS FOR USE, IFU0005 WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER "THE DEVICE IS DESIGNED TO ELECTROSURGICALLY PUNCTURE A HOLE IN THE TRANSGASTRIC OR TRANSDUODENAL WALL AND INTO A PANCREATIC PSEUDOCYST, WHEN IT IS VISIBLY BULGING INTO THE GASTROINTESTINAL TRACT¿. THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. (IFU0005) IMAGE REVIEW AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE ABNORMAL USE OF THE DEVICE. FROM THE INFORMATION AVAILABLE, CST-10 DEVICE WAS USED IN A PROCEDURE TO PUNCTURE A WOPN (WALLED-OFF PANCREATIC NECROSIS), THIS WAS CONFIRMED BY OUR MEDICAL ADVISOR AS ABNORMAL USE. AS PREVIOUSLY MENTIONED, THE IFU (IFU0005) STATES "THE DEVICE IS DESIGNED TO ELECTROSURGICALLY PUNCTURE A HOLE IN THE TRANSGASTRIC OR TRANSDUODENAL WALL AND INTO A PANCREATIC PSEUDOCYST, WHEN IT IS VISIBLY BULGING INTO THE GASTROINTESTINAL TRACT" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED IN THE INTENDED USE.¿ THE USER HAS NOT COMPLIED WITH THE REQUIREMENTS OF THE IFU WITH RESPECT TO THE INTENDED USE OF THE DEVICE. IT IS UNKNOWN HOW THE DEVICE WILL FUNCTION OUTSIDE OF ITS INTENDED USE. TRENDING WILL MONITOR IF ANY FUTURE INVESTIGATION IS REQUIRED. SUMMARY THE INVESTIGATION FINDINGS CONCLUDE THAT A DEFINITIVE ROOT CAUSE OF ABNORMAL USE WAS IDENTIFIED BASED ON THE AVAILABLE INFORMATION. A TOTAL OF 23 CASES OF ABNORMAL USE OF CST IN WOPN WERE REPORTED. THE COMPLAINT HAS BEEN CONFIRMED BASED ON CUSTOMER AND/OR REPRESENTATIVE TESTIMONY. ACCORDING TO THE INITIAL REPORTER, NO ADVERSE EFFECTS TO THE PATIENTS WERE REPORTED IN THE STUDY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR SIMILAR EVENTS.
CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.
DESCRIPTION OF EVENT: JAGIELSKI ET AL 2022 (C): THE ROLE OF ANTIBIOTICS IN ENDOSCOPIC TRANSMURAL DRAINAGE OF POST-INFLAMMATORY PANCREATIC AND PERIPANCREATIC FLUID COLLECTIONS PLACEMENT OF THE PANCREATICOGASTRIC OR PANCREATICODUODENAL ANASTOMOSIS IN THE FORM OF A TRANSMURAL CYSTOSTOMY WAS PERFORMED UNDER EUS GUIDANCE (JAGIELSKI ET AL., 2018; JAGIELSKI AND JACKOWSKI, 2021). THE ANASTOMOSIS BETWEEN THE GASTROINTESTINAL LUMEN AND THE COLLECTION CAVITY WAS CREATED USING A 10 FR CYSTOTOME (CYSTOTOME CST-10, COOK ENDOSCOPY INC., NORTH CAROLINA, USA) AND DILATED WITH A HIGH-PRESSURE BALLOON WITH A DIAMETER OF UP TO 15 MM (COOK ENDOSCOPY OR BOSTON SCIENTIFIC). THROUGH THE STOMY, A TRANSMURAL METAL JAGIELSKI ET AL. THE ANTIBIOTICS IN ENDOSCOPIC DRAINAGE OF PPPFCS. FOR ACTIVE TRANSMURAL DRAINAGE, A 7 FR OR 8.5 FR NASAL DRAIN (COOK ENDOSCOPY) AND 7 FR OR 8 FR DOUBLE PIGTAIL STENTS (COOK ENDOSCOPY) WERE INSERTED INTO THE COLLECTION CAVITY THROUGH THE LAMS. IN THE CASE OF PASSIVE (WITHOUT FLUSHING THROUGH NASOCYSTIC DRAINAGE) TRANSMURAL DRAINAGE, ONLY 7 FR OR 8.5 FR DOUBLE PIGTAIL STENTS (COOK ENDOSCOPY) WERE USED THROUGH LAMS. DRAINAGE SYSTEM. IF THE TRANSMURAL DRAINAGE SYSTEM DID NOT DRAIN THE ENTIRE NECROTIC AREA OR IF TRANSMURAL DRAINAGE WAS UNSUCCESSFUL FOR WOPN PATIENTS, DIRECT ENDOSCOPIC NECROSECTOMY WAS PERFORMED. THIS COMPLAINT CAPTURES THE OFF-LABEL USE: USE OF CST IN WOPN. PATIENT OUTCOME: NO ADVERSE EFFECTS TO THE PATIENT NOTED IN THIS STUDY.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 06-JAN-2025.
CANCELLATION REPORT BEING SUBMITTED AS THIS EVENT NO LONGER MEETS THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿. NO REPORTING MALFUNCTION PRECEDENCE EXISTS FOR THIS COMPLAINT EVENT FOR THIS PRODUCT FAMILY. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2373652 | CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE | KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC | KNS | COOK IRELAND LTD | G30550 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Male |