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

Catalog Number GEK-K

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

Patient Problems Fever (1858); Perforation (2001)

Event Type  Injury  

Event Description

During an endoscopic submucosal dissection (esd) procedure, the physician used a cook gel kit.The physician used the gel-k as a lifting agent in the proximal/mid rectum.A pre-lift with saline was established prior to injection of the gel.The procedure was completed, but new findings during the end of the procedure mandated surgery.In this case, the surgery was a normal next clinical step.The patient was admitted to the hospital for the next two days and then discharged.The patient came back to the hospital on (b)(6) 2014 with fever.The pathology results showed a micro-perforation.The physician concluded that a delayed perforation occurred.Additional info has been requested but not provided at this time.The physician concluded that a delayed perforation with fever had occurred.Additional info has been requested regarding the surgery and patient outcome but not provided at this time.

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 investigation is on-going.We are in the process of gathering more info regarding the description of the event and patient outcome.A follow up report will be submitted once that info is received.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusions: we are in the process of gathering more info regarding the description of the event and patient outcome.A follow up report will be submitted once that info is received.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 gel kit's are subjected to visual inspection to ensure device integrity.Corrective action: the need for corrective actions is still to be determined.We are in the process of gathering more info regarding the description of the event and patient outcome in order to determine if corrective actions are required.A follow up report will be submitted once that info is received.A review of the complaint history was conducted.There have been no other similar occurrences reported during the time period reviewed.Therefore, this report represents an isolated occurrence.Quality assurance will continue to monitor for complaint trends.

• 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: 4121351
• MDR Text Key: 4950114
• Report Number: 1037905-2014-00366
• 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: Physician
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GEK-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/19/2014
• 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): Other; Required Intervention