• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WILSON-COOK MEDICAL INC INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE; PKL, LIGATOR, HEMORRHOIDAL Back to Search Results
Model Number G58010
Device Problems Material Separation (1562); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Manufacturer Narrative
Pma/510(k): k212323 investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.A visual examination confirmed the clip housing has separated from the coil catheter but remains attached to the end of the drive wire, in a closed position.The clip could not be reopened.The device was viewed under magnification and a product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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: a corrective action has been initiated to reduce occurrences of the clip housing detaching from the cath attach for instinct plus endoscopic clipping devices.The product said to be involved is included in the scope of the corrective actions.The instructions for use states: "uncoil device.Verify smooth handle operation and clip action.Open clip by gently moving handle spool distally (away from handle thumb ring).Once clip is fully open, do not continue advancing handle spool as clip may prematurely detach from catheter.Close clip by moving handle spool proximally until clip is fully closed.Precaution: do not continue to pull handle spool beyond tactile resistance as this may prematurely deploy clip." the instructions for use states: "with clip closed and without holding handle spool, advance device in small increments into accessory channel of gastroscope, duodenoscope, or colonoscope.Note: if difficult to advance device, relax elevator and/or straighten endoscope.¿ the ifu also includes the following precaution: ¿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.Prior to distribution, all instinct plus endoscopic clipping devices 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 corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
 
Event Description
A complaint had been registered for cook instinct endoscopic hemoclips not functioning in the endoscope.Devices were returned for evaluation, and one (1) instinct plus endoscopic clipping device housing had detached from the catheter attach [tromboning] (subject of this report).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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSTINCT PLUS ENDOSCOPIC CLIPPING DEVICE
Type of Device
PKL, LIGATOR, HEMORRHOIDAL
Manufacturer (Section D)
WILSON-COOK MEDICAL INC
4900 bethania station rd
winston-salem NC 27105
Manufacturer (Section G)
COOK ENDOSCOPY
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
sabrina o'brien
4900 bethania station rd
winston-salem, NC 27105
3367440157
MDR Report Key16635682
MDR Text Key312290472
Report Number1037905-2023-00144
Device Sequence Number1
Product Code PKL
UDI-Device Identifier00827002580107
UDI-Public(01)00827002580107(17)250222(10)W4568179
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG58010
Device Catalogue NumberINSC-P-7-230-S
Device Lot NumberW4568179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
OLYMPUS ENDOSCOPE UNKNOWN MODEL
-
-