MAUDE Adverse Event Report: COOK INC APPEL-BERCI CYSTIC DUCT INTRODUCER SET; GBZ; CATHETER, CHOLANGIOGRAPHY

Model Number	G08297
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that hair-like foreign matter was identified within the sealed packaging of an appel-berci cystic duct introducer set.It was then decided that the device would not be used.No harm has currently been reported.Additional information regarding event details has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.B3: date of event: event date was reported to be "last week".E3: occupation: materials specialist.G4: pma/510(k) #: exempt.H3: device evaluated by mfg?: it is unknown if the complaint device will be returned to the manufacturer this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3: device evaluation anticipated, but not yet begun.Correction: h6 (annex f).Additional information: b3 - date of event, b5, d4: lot number, d4: udi, d4: expiration date, d9 (device available for evaluation), e4.H4 (device manufacture date); h3.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information was provided on 09apr2026.The contaminated device did not reach the patient.In regard to how the procedure was completed; there was no delay or harm.The customer had more on hand to use.They just couldn't use the contaminated one.

• Brand Name: APPEL-BERCI CYSTIC DUCT INTRODUCER SET
• Common Device Name: GBZ; CATHETER, CHOLANGIOGRAPHY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 24781891
• Report Number: 1820334-2026-00367
• Device Sequence Number: 10036563
• Product Code: GBZ
• UDI-Device Identifier: 00827002082977
• UDI-Public: (01)00827002082977(17)280903(10)16769680
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2026

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 Model Number: G08297
• Device Catalogue Number: C-CDIS-4.0-15-BERCI
• Device Lot Number: 16769680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/09/2026; 05/26/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/14/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown