• 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 ENDOSCOPIC HEMOCLIP; 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 ENDOSCOPIC HEMOCLIP; PKL, LIGATOR, HEMORRHOIDAL Back to Search Results
Catalog Number INSC-7-230-S
Device Problems Device Dislodged or Dislocated (2923); Migration (4003)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2018
Event Type  malfunction  
Event Description
During a clipping procedure, the physician used a cook instinct endoscopic hemoclip.After clips were used to close the submucosal tunnel, the tunnel was again inspected.One clip dislodged [from the tissue] with this maneuver and was removed and replaced.An unintended section of the device did not remain in the patient's body.It was not noted in the data reported if any adverse effects were noted, but it is reasonable to conclude that the patient was not adversely impacted.
 
Manufacturer Narrative
This event is under investigation.A follow up emdr will be sent.
 
Manufacturer Narrative
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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Prior to distribution, all instinct endoscopic hemoclips 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INSTINCT ENDOSCOPIC HEMOCLIP
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 Key14515251
MDR Text Key297736416
Report Number1037905-2022-00256
Device Sequence Number1
Product Code PKL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132809
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberINSC-7-230-S
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/28/2022
Initial Date FDA Received05/26/2022
Supplement Dates Manufacturer Received04/28/2022
Supplement Dates FDA Received06/23/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
ENDOSCOPE, UNKNOWN MAKE OR MODEL
-
-