MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC; KNQ, DILATOR, ESOPHAGEAL

Model Number	G51798
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report and determined the catheter was cracked at the user end.During a visual examination, a crack was observed approximately 14.5 cm from the distal end within the silver ink mark.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 conclusion: a corrective action has been initiated to reduce occurrences of catheter cracking, splitting or breaking for hbd-w devices.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all hercules 3 stage wire guided balloons esophageal-pyloric-colonic are subjected to a leak test to ensure device integrity.A review of the device history record 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.A corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
Prior to a procedure, the nurse opened the packaging of a cook hercules 3 stage wireguided balloon esophageal-pyloric-colonic finding it to be already broken.Another device was used to complete the procedure.There was no reportable information at this time.Additional information received on 10/18/2019 from the customer noting the catheter was torn apart or broken from the white holder [user end].They saw it immediately when they opened the package.There was no reportable information at this time.Additional information received on 10/29/2019 when the device was returned, noting the catheter was broken at the user end.This observation was made prior to patient contact; there was no impact to the patient.

• Brand Name: HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9356009
• Report Number: 1037905-2019-00713
• Device Sequence Number: 19387905
• Product Code: KNQ
• UDI-Device Identifier: 00827002517981
• UDI-Public: (01)00827002517981(17)220826(10)W4254260
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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 Expiration Date: 08/26/2022
• Device Model Number: G51798
• Device Catalogue Number: HBD-W-18-19-20
• Device Lot Number: W4254260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1