MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. 11MM XCEL STABILITY SLEEVE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	CB11LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional 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 device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that during a laparoscopic nissen fundoplication, after inserting the trocar into the patient and inserting an instrument into the trocar, the doctor noticed a tiny piece of plastic dislodged as the instrument was inserted through the trocar, into the patient.The doctor was able to retrieve the tiny piece of plastic from the patient.The doctor continued to use the same trocar to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Batch # n92v1r, n92n8l.Device analysis: the analysis results found that the cb11lt device was returned with no damage in the external components.In addition, the obturator was not returned along with the instrument.The device was visually inspected and no missing pieces were observed from the sealing components.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: 11MM 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: 7128265
• Report Number: 3005075853-2017-06864
• Device Sequence Number: 11125593
• Product Code: GCJ
• UDI-Device Identifier: 20705036001321
• UDI-Public: 20705036001321
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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 Expiration Date: 08/31/2021
• Device Catalogue Number: CB11LT
• Device Lot Number: N4M26H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1