INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE

Report

Report Number: 1037905-2024-00391
Event Type: Malfunction
Date Received: July 17, 2024
Date of Event: June 7, 2024
Report Date: November 21, 2024
Manufacturer: WILSON-COOK MEDICAL INC
Product Code: PKL
UDI-DI: 00827002580107
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

510(K): K212323. THIS INVESTIGATION IS ONGOING. WE WILL SUBMIT A FOLLOW-UP EMDR WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

Additional Manufacturer Narrative · 0

510(K): K212323 INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN A CLEAR PLASTIC BAG WITH AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. ADDITIONALLY, 3 SEALED DEVICES FROM THE LOT NUMBER IN THE REPORT WERE RETURNED AND EVALUATED. USED DEVICE: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT AS IT WAS DESCRIBED, BECAUSE ALL THE DEVICE COMPONENTS (PARTICULARLY THE CLIP) WERE NOT INCLUDED IN THE RETURN. DURING FUNCTIONAL TESTING THE DEVICE WAS ADVANCED INTO THE ACCESSORY CHANNEL OF A PENTAX COLONOSCOPE (2.8 MM CHANNEL) WHICH WAS PLACED IN A SIMULATED LOWER GI POSITION. THE TIP OF THE ENDOSCOPE WAS RETROFLEXED TO SIMULATE WORST CASE SCENARIO. WITH HANDLE MANIPULATION, THE DRIVE WIRE WAS OBSERVED TO MOVE FREELY INSIDE THE OUTER SHEATH. A VISUAL EXAMINATION OF THE DRIVE WIRE, CATHETER ATTACHMENT, AND COIL CATHETER (DISTAL END DEVICE COMPONENTS) SHOWED NO DEFORMITIES OR SIGNS OF DAMAGE. A PRODUCT DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OCCURRENCE WAS NOT OBSERVED. SEALED DEVICES: THE DEVICES WERE FUNCTION TESTED FOR OPEN/CLOSE ONCE ADVANCED DOWN THE ENDOSCOPE. THE CLIPS ADVANCED THROUGH THE SCOPE, OPENED, AND CLOSED AS EXPECTED. ADDITIONALLY, THE CLIPS DID NOT PREMATURELY DEPLOY AND THE HOUSING DID NOT DETACH FROM THE CATH ATTACH. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED FOR THE SEALED DEVICES. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: USED DEVICE: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED COULD NOT CONFIRM THE REPORT. THE ADDITIONAL INFORMATION INDICATED THE USER HELD THE HANDLE SPOOL DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL. THIS IS THE MOST LIKELY CAUSE OF THIS REPORT. SEALED DEVICES: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE PRODUCT SAID TO BE INVOLVED FUNCTIONED AS INTENDED. A DISCREPANCY OR ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR USE STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE OR COLONOSCOPE. CAUTION: HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP." FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. HOWEVER, EVEN IF THE CLIP IS NOT DEPLOYED, DAMAGE CAN OCCUR TO INTERNAL DEVICE COMPONENTS SUCH AS THE DRIVER LEGS. ONCE THIS DAMAGE OCCURS, THE CLIP IS IN A PARTIALLY DEPLOYED STATE AND MAY NOT BE ABLE TO BE OPENED/REOPENED. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT THE USER HELD THE HANDLE SPOOL DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL, A COOK AREA REPRESENTATIVE STATED THAT TRAINING WAS PROVIDED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

Additional Manufacturer Narrative · 0

510(K): (B)(4). INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: THE ADDITIONAL INFORMATION INDICATED THE USER HELD THE HANDLE SPOOL DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL. THIS IS THE MOST LIKELY CAUSE OF THIS REPORT. THE INSTRUCTIONS FOR USE STATES: "WITH CLIP CLOSED AND WITHOUT HOLDING HANDLE SPOOL, ADVANCE DEVICE IN SMALL INCREMENTS INTO ACCESSORY CHANNEL OF GASTROSCOPE OR COLONOSCOPE. CAUTION: HOLDING HANDLE SPOOL DURING CLIP ADVANCEMENT MAY PREMATURELY DEPLOY CLIP." FAILURE TO FOLLOW THE INSTRUCTIONS ABOVE CAN RESULT IN DAMAGE TO THE DEVICE WHICH MAY LEAD TO PREMATURE CLIP DEPLOYMENT. HOWEVER, EVEN IF THE CLIP IS NOT DEPLOYED, DAMAGE CAN OCCUR TO INTERNAL DEVICE COMPONENTS SUCH AS THE DRIVER LEGS. ONCE THIS DAMAGE OCCURS, THE CLIP IS IN A PARTIALLY DEPLOYED STATE AND MAY NOT BE ABLE TO BE OPENED/REOPENED. PRIOR TO DISTRIBUTION, ALL INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE. ADDITIONAL COMMENTS: BASED ON THE INFORMATION PROVIDED THAT THE USER HELD THE HANDLE SPOOL DURING ADVANCEMENT THROUGH THE ACCESSORY CHANNEL, A COOK AREA REPRESENTATIVE STATED THAT TRAINING WAS PROVIDED IN AN EFFORT TO PROMOTE FURTHER EDUCATION AND UNDERSTANDING RELATED TO APPROPRIATE USAGE OF THIS PRODUCT.

Description of Event or Problem · 0

DURING A COLONOSCOPY IN THE COLON AFTER A POLYPECTOMY, THE PHYSICIAN SELECTED A COOK INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE. IT WAS REPORTED THAT THE DOCTOR WANTED TO PUT A CLIP BECAUSE OF BLEEDING. THE NURSE INSERTED THE CLIP AND WHEN IT CAME OUT, IT WAS IMPOSSIBLE TO OPEN IT. IT WAS ALMOST SEPARATED FROM ITS SHEATH [TROMBONING: CLIP HOUSING DETACHED FROM THE CATH ATTACH]. THE NURSE USED A NEW ON TO CLOSE THE BLEEDING. THE NURSE WHO USED THE CLIP WAS VERY STRESSED AND TOLD [THE AREA REP] THAT MAYBE SHE TIGHTENED THE CLIP A LITTLE TOO HARD BEFORE INSERTING INTO THE WORKING CHANNEL OF THE COLONOSCOPE. THE DIFFICULTY IS THAT THEY USE 3 TYPE OF CLIPS DIFFERENT AND SHE IS NEW IN THE SERVICE. A TRAINING OF THE CLIP WAS HELPFUL FOR HER AND NOW, IT MIGHT RUN PERFECTLY. THE CLIP WAS CLOSED AND THEY LEFT INTO THE COLON IN ORDER TO BE ELIMINATED NATURALLY. 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2145183	INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE	PKL, LIGATOR, HEMORRHOIDAL	PKL	WILSON-COOK MEDICAL INC	G58010	W4809506	00827002580107

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown		COLONOSCOPE FUJI 700.