MAUDE Adverse Event Report: COOK INC WILLIAMS CYSTOSCOPIC INJECTION NEEDLE; FBK ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: analyst.A follow up report will be submitted should additional relevant information become available.

Event Description

At an unknown point of a cystoscopy, a williams cystoscopic injection needle broke.It was stated that no portion of the needle remained within the patient.It is unknown how the procedure was finished.No adverse effects to the patient have been reported due to this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation-evaluation reviews of complaint history, device history record, quality control data, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The complaint device was not returned for evaluation.Although requested, additional details concerning the broken needle were not provided.A review of the device history record found the nonconformance's that were recorded were not related to the reported failure mode.A review of the device master record shows all needles are inspected for hub separation prior to distribution.The complaint is confirmed upon customer testimony.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The cause of the broken needle was traced to the user.Unintended use error most likely caused the reported device malfunction.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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 cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information received on (b)(6) 2019: the broken needle was discovered during the procedure but before introducing into the patient.Another needle of the same type was used to complete the procedure after the difficulty occurred.

• Brand Name: WILLIAMS CYSTOSCOPIC INJECTION NEEDLE
• Type of Device: FBK ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8912499
• MDR Text Key: 155009760
• Report Number: 1820334-2019-02054
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 00827002152960
• UDI-Public: (01)00827002152960(17)211231(10)9413674
• Combination Product (y/n): N
• PMA/PMN Number: K812057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 090001-S10
• Device Lot Number: 9413674
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1