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

Catalog Number CB5ST

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported by the sales rep that during a laparoscopic hysterectomy, the tip of the sleeve was deformed thinly, and forceps caught at the trocar during use.The same device was used as is to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: 8776733
• MDR Text Key: 151013693
• Report Number: 3005075853-2019-20320
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001355
• UDI-Public: 10705036001355
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2019

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 Catalogue Number: CB5ST
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1