MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 12MM XCEL STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number CB12LT

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during a gastric sleeve, the trocar tip melted.A similar device was used to complete the case.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 2/11/2020.Investigation summary: the analysis results found that the cb12lt device was received with the tip of the sleeve melted.One possible cause for this type of damage may be interaction with an energized device used during the procedure.Caution should be taken to avoid contact between an energized device and the trocar during the surgical procedure.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.

• Brand Name: 12MM XCEL STABILITY SLEEVE
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9594129
• MDR Text Key: 202553713
• Report Number: 3005075853-2020-00341
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: 10705036001331
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CB12LT
• Device Catalogue Number: CB12LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1