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

Catalog Number	CTB12LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 prior to an endoscopic right colectomy, before use on the patient, the packaging was broken.Another like product was used to complete the procedure.There is no report on the patient¿s injury.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/08/2017.D4: batch # p9220n.D4: lot # p4re4t, p4rf6t, p4rh13, p4rh7c.H10: corrected data: d4 catalog: ctb5lt to ctb12lt.Device analysis: the analysis results found that a ctb12lt device was returned outside its original package.It could not be determined what may have cause the reported event.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.
Additional Manufacturer Narrative
(b)(4).This report is being submitted per the request of fda to correct sequential numbering for the mdr follow up report originally submitted.This is follow up report #1.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/04/2017.Per photographic evaluation: upon visual inspection of the picture, the stopcock appears to be separated form the sleeve.Refer to physical analysis for details on investigation.

• Brand Name: BASX BLADELESS SLEEVE 12MM
• Common Device Name: 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: 6973156
• Report Number: 3005075853-2017-05624
• Device Sequence Number: 19170492
• Product Code: GCJ
• UDI-Device Identifier: 20705036001512
• UDI-Public: 20705036001512
• Combination Product (Y/N): N
• PMA/510(K) Number: K062209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2017

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: 03/31/2022
• Device Catalogue Number: CTB12LT
• Device Lot Number: P4RR66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 11/06/2024; 10/31/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/13/2024; 11/08/2017
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG