MAUDE Adverse Event Report: COOK INC FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS; FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY

Model Number	G56430
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a transurethral lithotomy (tul) and using a flexor parallel ureteral access sheath and dilator, there was a fiber-like foreign matter in the sheath.The device was inserted and placed in the ureter with a wire guide.As the physician was advancing the flexible ureteroscope in the reported sheath, they noticed the fiber-like foreign matter in the sheath.They had suspicion of the inside coating of the sheath peeling.Another sale type device was use to complete the procedure.No adverse events to the patient were reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Event summary: as reported, during a transurethral lithotomy (tul) and using a flexor parallel ureteral access sheath and dilator, there was a fiber-like foreign matter in the sheath.The device was inserted and placed in the ureter with a wire guide.As the physician was advancing the flexible ureteroscope in the reported sheath, they noticed the fiber-like foreign matter in the sheath.They had suspicion of the inside coating of the sheath peeling.Another sale type device was used to complete the procedure.No adverse events to the patient were reported.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One device was returned in an opened outer package.The inside of the sheath appeared to have shredded coating, most prominently in the inside hub of the sheath.A wire was inserted into the dilator, and no substance was noted to be pushed out.Delamination of the inner sheath was confirmed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.No gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device is provided with instructions for use which state, "prior to placement, activate the hydrophilic coating by removing the dilator from the flexor sheath and immersing all components in sterile water or isotonic saline.This will allow the hydrophilic surface to absorb water and become lubricious, easing placement under standard conditions.¿ based on the available information, cook has concluded that the most probable cause for the reported event could not be determined.It is possible that the ureteroscope used inadvertently scrapped the inner coating of the sheath during use, but this could not be confirmed.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
• Common Device Name: FED ENDOSCOPIC ACCESS OVERTUBE/GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12140194
• Report Number: 1820334-2021-01724
• Device Sequence Number: 14319925
• Product Code: FED
• UDI-Device Identifier: 00827002564305
• UDI-Public: (01)00827002564305(17)230203(10)10304972
• Combination Product (Y/N): N
• PMA/510(K) Number: K172217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 02/03/2023
• Device Model Number: G56430
• Device Catalogue Number: FUS-095035-P
• Device Lot Number: 10304972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KARL STORZ FLEX-X K11278A1