MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC. GEL KIT; FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Catalog Number GEL-K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); No Consequences Or Impact To Patient (2199)

Event Date 12/18/2014

Event Type  Injury  

Event Description

During an endoscopic submucosal dissection procedure, the physician used a cook gel kit.The muscle split and a perforation occurred.Clips were needed to close the perforation.A section of the device did not remain inside the patient's body.Other than using clips to close the perforation, 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.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: 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.The safe and effective use of this device is highly dependent upon factors under the control of the operator.The instructions for use instruct the user to insert needle into the elevated submucosa (starter bleb) and inject gel by rotating knob of handle in a clockwise manner to achieve desired tissue elevation.Per the instructions for use, there is no substitute for a properly trained endoscopy staff.It is important that instructions supplied with this device are read, understood and followed before use.Muscularis perforation is listed as a potential complication per the instructions for use.The instructions for use warn the user not to exceed the 1500 psi recommended working pressure.Prior to distribution, all gel kits are subjected to a visual inspection to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.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: GEL KIT
• Type of Device: FBK, ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC.; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr. ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4452626
• MDR Text Key: 5384583
• Report Number: 1037905-2015-00021
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GEL-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2014
• Event Location: Hospital
• Date Manufacturer Received: 12/24/2014
• 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 Number: 1
• Treatment: ENDOSCOPE (UNK TYPE)
• Patient Outcome(s): Required Intervention