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

Model Number CTB12LT

Device Problems Component or Accessory Incompatibility (2897); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2022

Event Type  malfunction  

Event Description

It was reported that during a gastric bypass, the trocar seal was leaking.The leakage is caused by the seal being damaged from the endo-gia stapler being removed through the trocar.Procedure prolonged 5 minutes.No patient consequences.

Manufacturer Narrative

(b)(4).Batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4) date sent: 2/14/2023 d4: batch # unk this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the video shows a surgery when the stapler is removed from the trocar.Unfortunately, the video does not provide sufficient evidence to determine the root cause and the damage reported in the seal.Practical analysis should provide the necessary evidence to confirm the root cause.Based on the photo review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing documentation could not be completed as the lot number was not provided.

• Brand Name: BASX BLADELESS SLEEVE 12MM
• Type of Device: 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16194539
• MDR Text Key: 308844528
• Report Number: 3005075853-2023-00383
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001515
• UDI-Public: 10705036001515
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K062209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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 Model Number: CTB12LT
• Device Catalogue Number: CTB12LT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2023
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1