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

Model Number	G56435
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Name and address: postal code: (b)(6).Occupation = non-healthcare professional - unknown.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, foreign matter was confirmed inside the unopened package of a fus-120035-p by the distributor.There was no contact with patients.
Event or Problem Description
No new information to report that was not included on the previous medwatch report.
Additional Manufacturer Narrative
Summary of event: as reported, foreign matter was confirmed inside the unopened package of a fus-120035-p by the distributor.There was no contact with patients.Investigation evaluation: reviews of complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The customer returned the device to cook for investigation.A physical examination of the returned device showed 1 unopened device was received.The entire package was examined and the suspected foreign matter could not be located.Upon opening the package, the foreign matter was discovered.In response to this incident, cook completed a review of the device history record (dhr).The dhr reported 3 non-conformances.Cook concluded that 2 non-conformances were not related to this incident.Although, 1 non-conformance was relevant to the reported failure mode.All non-conforming products were scrapped and there are 100% inspections to capture this non-conformance.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product instructions for use (ifu) provides the following information to the user related to the reported failure mode: ¿how supplied¿ ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The complaint was confirmed based on customer testimony and investigation of the returned device.Cook has concluded that the main cause of failure is manufacturing related.A dark fiber is visible within the sealed packaging.Though there are 100% inspections in place to detect foreign matter, it is still possible for this failure to not be caught.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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: 12149937
• Report Number: 1820334-2021-01744
• Device Sequence Number: 20037860
• Product Code: FED
• UDI-Device Identifier: 00827002564350
• UDI-Public: (01)00827002564350(17)240422(10)NS13914201
• 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: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 04/22/2024
• Device Model Number: G56435
• Device Catalogue Number: FUS-120035-P
• Device Lot Number: NS13914201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1