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

Catalog Number	CB5ST
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unknown.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8776733
• Report Number: 3005075853-2019-20320
• Device Sequence Number: 11429341
• Product Code: GCJ
• UDI-Device Identifier: 10705036001355
• UDI-Public: 10705036001355
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: CB5ST
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/10/2019
• Patient Sequence Number: 1