MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC GEL KIT

Catalog Number GEL-K

Device Problems Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Perforation (2001)

Event Date 05/22/2014

Event Type  Injury  

Event Description

During an endoscopic submucosal dissection (esd) procedure, the physician used a cook gel kit.The physician reported a complication during the esd case using the gel kit on a lesion located at the gastro-esophageal junction.Initial injection of saline was performed as practiced in other area of gi tract.Then, gel was injected at gastro-esophageal junction with bleb on straight view.During the case, he noticed some pockets created by the gel.They looked like they were created within submucosa but appeared deep.When he cut into the submucosal space near the pockets, he realized that they were formed within the muscularis propria as he could visualize the serosa.It was noted that the muscle was split and this caused pain to the patient.The deep pocket appeared not to have penetrated the serosa.At the end of the completed resection, clips and endoscopic sutures were placed to prevent delayed perforation and a stent was placed.A section of the device did not remain inside the patient's body.The injection into the muscle was painful to the patient.The patient required clips, sutures and a stent due to this occurrence.The patient was observed for 2 days and then discharged.The patient did not require any other additional procedures due to this occurrence.According to the initial reporter, the patient did no experience any adverse effects due to this occurrence.

Manufacturer Narrative

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 determined.A review of the device history record could not be conducted because the lot number was not provided.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 control of the operator.Prior to distribution, all gel kits are subjected to a visual inspection to ensure device integrity.A review of the complaint history was conducted and this represents an unusual 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
• 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: 3934851
• MDR Text Key: 4575813
• Report Number: 1037905-2014-00251
• 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: Other
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• 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: 05/22/2014
• Event Location: Hospital
• Date Manufacturer Received: 05/27/2014
• 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): Hospitalization; Required Intervention