MAUDE Adverse Event Report: COOK INC SALIVARY STONE EXTRACTOR BASKET SSEB; GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Concomitant products: sseb-1.5-115-10.Related reports: mfg reference # 1820334-2019-01449.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that during a sialendoscopy procedure to remove salivary gland stones, the salivary stone extractor basket wore out and wouldn't close after multiple uses.The physician stated, "it worked for a while, but ultimately stopped closing" as reported, no adverse effects were experienced by the patient due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of documentation including the complaint history, device history record, instructions for use, manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination of the device not conducted.However, a document-based investigation evaluation was performed.It was concluded that the device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record showed no nonconformances in lot 9639977 that could have contributed to the failure of the device.It should be noted that there have been no other complaints reported for this lot number.There is no evidence to suggest that nonconforming exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: caution: this device is conductive.Avoid contact with any electrified instrument.Sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Excessive force could damage device.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.The salivary stone extractor basket is a disposable, single use device, and as such, has a limited number of open/close cycles.It appears that device functioned normally for a period of time, but repeated usage eventually caused the basket not to close.Procedural factors would affect the life of the device factors such as size and shape of the stones, the path the device was in during use and forces applied to the device.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified and we will continue to monitor for similar complaints.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.

Event Description

No new event description information to report at this time.

• Brand Name: SALIVARY STONE EXTRACTOR BASKET SSEB
• Type of Device: GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8692334
• MDR Text Key: 147887039
• Report Number: 1820334-2019-01448
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00827002237988
• UDI-Public: (01)00827002237988(17)220403(10)9639977
• Combination Product (y/n): N
• PMA/PMN Number: K120468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Model Number: N/A
• Device Catalogue Number: SSEB-1.7-115-8
• Device Lot Number: 9639977
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR