MAUDE Adverse Event Report: COOK ENDOSCOPY FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number	FLOW-20-PULL-S
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional 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 nonconformances documented 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 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.The instructions for use (ifu) states the following precaution: "during placement and use, care must be taken to avoid cutting, crimping, or damaging components." if additional pressure is applied to accessory components, this could contribute to accessory component damage.Prior to distribution, all flow 20 percutaneous endoscopic gastrostomy set - pulls are subjected to a visual inspection and functional testing to ensure device integrity.A review of the nonconformances documented for the lot number said to be involved was reviewed and confirmed that this lot met manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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.Additional comments regarding this report: based on the information provided that the fellow did not introduce the trocar correctly, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event or Problem Description
During a percutaneous endoscopic gastrostomy (peg), the physician used a cook flow 20 percutaneous endoscopic gastrostomy set - pull.The clinical staff reported to district manager that the procedure was being done by a fellow with an attending physician next to him.The fellow did not introduce the trocar correctly.The sheath of the needle [plastic cannula] broke inside the patient.The attending physician decided not to look for the broken piece.He decided to send the patient for a surgical evaluation.Additional information was received on 05/07/2018 during a phone conversation with the cook area representative: the gastroenterologist did not want to look for the device fragment that broke off in the patient's stomach.He sent the patient for a surgical evaluation to determine if the fragment should be surgically removed.Surgery chose not to intervene and allowed the fragment to pass naturally.The patient required an additional medical procedure to replace the peg tube.The patient did not experience any adverse effects.

• Brand Name: FLOW 20 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7544237
• Report Number: 1037905-2018-00225
• Device Sequence Number: 10795802
• Product Code: KNT
• UDI-Device Identifier: 00827002226388
• UDI-Public: (01)00827002226388(17)181027(10)W3934280
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: FLOW-20-PULL-S
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/01/2018
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1