MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CUR.ADJ.BAND WITH PORT+APPLIER; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

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.Following information requested but unavailable: what date was the band implanted? why was the band removed? are there plans to retrieve the piece at a later time?.

Event Description

It was reported that during the removal of the band, the white cup was not found when the casing was removed.Foreign part retained on the patient, not found.No additional actions were taken.

Manufacturer Narrative

(b)(4).Date sent: 1/9/2020.Additional information: a manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: CUR.ADJ.BAND WITH PORT+APPLIER
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9357805
• MDR Text Key: 200456933
• Report Number: 3005075853-2019-23671
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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 Expiration Date: 10/31/2014
• Device Catalogue Number: BD3XV
• Device Lot Number: ZKNBD8
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/09/2020
• Patient Sequence Number: 1