MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. INSTINCT ENDOSCOPIC HEMOCLIP; FHN, LIGATOR, HEMORRHOIDAL

Catalog Number INSC-7-230-S

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

During an endoscopy procedure, a cook instinct endoscopic hemoclip was used.The clip deployed itself in the endoscope.The deployed clip was seen in the patient not clipped to anything.The prematurely deployed clip was left in the patient to pass.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

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 conclusions: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause of 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 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.

• Brand Name: INSTINCT ENDOSCOPIC HEMOCLIP
• Type of Device: FHN, LIGATOR, HEMORRHOIDAL
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3820703
• MDR Text Key: 4389986
• Report Number: 1037905-2014-00124
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2017
• Device Catalogue Number: INSC-7-230-S
• Device Lot Number: W3382773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS GIF HQ150 ENDOSCOPE