MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 5MM XCEL STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number CB5LT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Possible batch numbers: r93p57 and r93p3c.Investigation summary: the analysis results found that the cb5lt instrument was received with the sleeve melted.This type of damage is consistent with the one produced by an energized device.In addition, the tyvek packaging was returned along with the instrument.In order to prevent this kind of damage, please avoid contact with laser, electrosurgical, or ultrasonic devices.The lot and batch history records was reviewed and no defects, ncr¿s, or protocols related to the complaint were found during the packaging process.

Event Description

It was reported that during a laparoscopic sleeve gastrectomy procedure, a piece of plastic was loose inside the housing.The procedure was completed with an alternate like device with no patient consequence reported.

• Brand Name: 5MM 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8071701
• MDR Text Key: 129072086
• Report Number: 3005075853-2018-14385
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001348
• UDI-Public: 10705036001348
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: CB5LT
• Device Lot Number: R40M8L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1