MAUDE Adverse Event Report: COOK INC TRANSLUMINAL BILIARY BIOPSY FORCEPS MINIMAL SET

Model Number	N/A
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, during a liver biopsy, the forceps in the transluminal biliary biopsy forceps minimal set partially detached from the introducer.However, they were still attached by a small thread.The operator of the device changed the forceps set.No patient adverse events were reported as a result of the reported product issue.The product is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the device history record, documentation, manufacturing instructions, specifications, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual examination of the returned device noted that the sheath was loose from the fitting.When actuated, the separation was visible.A functional test was also performed, and the handle actuated the forceps to the open and closed positions.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: TRANSLUMINAL BILIARY BIOPSY FORCEPS MINIMAL SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7013527
• Report Number: 1820334-2017-03796
• Device Sequence Number: 2037676
• Product Code: FCL
• UDI-Device Identifier: 00827002352155
• UDI-Public: (01)00827002352155(17)200830(10)8041987
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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 Model Number: N/A
• Device Catalogue Number: BBFS-100-MS
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 50