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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	04/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event was not provided.Patient sex at time of event was not provided.(b)(4).This event is currently under investigation.
Event or Problem Description
The salivary stone extractor basket was deployed the around the stone just fine.When the doctor tried to remove the basket, the stone approximately 5mm x 7mm, was too large for removal.A balloon was used to dilate the duct but the basket would not budge.An attempt was made to get the basket off the stone but it got stuck and the doctor was unable to remove it.A cut down was done to remove the stone and the basket.The doctor indicated that due to the size of the stone he would have had to do a cut down anyway, but the basket should have come off the stone.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Correction to date received by mfr initial was filed within the 30 day time frame regardless of corrected date.Investigation/evaluation during the course of the investigation, a visual inspection, along with a review of the complaint history, quality control, specifications, documentation, manufacturing instructions, and a drawing of the returned product was conducted.The device was returned with the basket formation and 28 cm of the coil assembly severed and stretched.A visual examination of the basket formation noted that it was misshapen and asymmetrical.A severe kink was noted at the base of the support sheath.The basket sheath was stretched 10 cm starting at the distal tip.Another severe kink was noted at 15 cm from the distal tip.The handle was disassembled and the support sheath and basket sheath were noted to still be attached.The basket formation could be manually actuated.The device is packaged with an ifu which gives the device description, intended use, warnings, precautions and potential adverse events for use of this device.The ifu states that "if resistance is encountered while attempting to remove calculi or other foreign bodies, release the object.Excessive force could damage the device." also "if the basket does not readily release the captured object, further manipulation may be necessary.Finally, the ifu lists "tissue avulsion" as a potential adverse event.A definitive root cause could not be determined.The appropriate internal personnel have been notified, and we will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
Event or Problem Description
The salivary stone extractor basket was deployed around the stone just fine.However, when the doctor tried to remove the basket, the stone (approximately 5mm x 7mm), was too large for removal.A balloon was used to dilate the duct but the basket would not budge.An attempt was made to get the basket off the stone but it got stuck and the doctor was unable to remove it.A cut down was done to remove the stone and the basket.The doctor indicated that due to the size of the stone he would have had to do a cut down anyway, but the basket should have come off the stone.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: SALIVARY STONE EXTRACTOR BASKET SSEB
• Common Device Name: GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5634469
• Report Number: 1820334-2016-00303
• Device Sequence Number: 175279
• Product Code: GCJ
• UDI-Device Identifier: 00827002237971
• UDI-Public: (01)00827002237971(17)181014(10)6286411
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K120468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SSEB-1.5-115-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2016
• Device Age: 7 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2016
• Supplement Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention