MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 12X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number 2B12LT

Device Problem Crack (1135)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 11/22/2023.Additional information was requested and the following was obtained: "what is the surgeons experience with the device? used for every robotic case - multiple robotic cases per day/5 days a week.2.What is the patients bmi? unknown.3.What action was being performed when the device broke? robotic laparoscope was removed/inserted into trocar for cleaning for better visibility.4.Were there any other intra op complications? unknown.5.What instruments were passed through the trocar? robotic laparoscope.6.Were any heated instruments passed through the trocar? no.7.Does the account use reprocessed trocars or does the account reprocess the trocars in house at the account? we do not reprocess our disposables.8.Are there currently any retrieval or follow up plans for the possible piece left in the patient? unknown.9.What is the current patient status? unknown".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.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.

Event Description

It was reported that during a lap hysterectomy, camera was placed in and out of port site multiple times before trocar sleeve broke apart.Trocar sleeve could not be put back together and confirmation that the scrub nurse had all the pieces back could not be verified.Xray done post op as per retained product policies.

Manufacturer Narrative

(b)(4).Date sent: 12/29/2023.D4: batch # a9dc9h.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the 2b12lt device was returned with the universal seal component disassembled and inside aplastic bag.Upon evaluation of the device was observed to be not properly welded.In addition, the tyvek was returned along with the instrument.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No conclusion could be reached regarding what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2024 d4: batch # unk investigation summary: "all pieces of the trocar were identified to be returned." upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a serious injury and is being considered a malfunction.

• Brand Name: OPT BLADELESS 12X100 STABILITY
• 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: 18191843
• MDR Text Key: 328802774
• Report Number: 3005075853-2023-08689
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036014218
• UDI-Public: 10705036014218
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2B12LT
• Device Lot Number: 526C86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/04/2023; 01/04/2024
• Supplement Dates FDA Received: 12/29/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other