MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS TROCAR 12MM; BASX TROCAR

Catalog Number TB12LT

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

The rubber seal has slipped through the trocar sleeve into the situs.The rubber seal was removed from the situs.No harm to the patient.

Manufacturer Narrative

(b)(4).Batch # r92p2j, r92e77.Per photographic analysis: there was no sample received for analysis.Only pictures of the sample were received for analysis.Upon visual inspection of the pictures, it appears like the duckbill was separated from the device.However, no definitive conclusion could be reached as to the cause of the reported incident as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Manufacturer Narrative

(b)(4).Device analysis: the analysis results found that tb12lt device was received with the universal seal cap separated from the universal seal base.During visual examination, was noted to have insufficient welding resulting in the universal seal cap and the universal seal base being separated and the inner seal assembly out of position.Therefore, this is associated to not being properly welded during the manufacturing process.

• Brand Name: BASX BLADELESS TROCAR 12MM
• Type of Device: BASX TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7598702
• MDR Text Key: 111440491
• Report Number: 3005075853-2018-10606
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036003004
• UDI-Public: 20705036003004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2018

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: 02/28/2023
• Device Catalogue Number: TB12LT
• Device Lot Number: R4099Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 05/30/2018; 01/10/2019
• Supplement Dates FDA Received: 06/28/2018; 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1