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

Model Number	2CB12LT
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information received: a video was received for review.Review is in progress and has not yet been completed.Upon completion of video review, a supplemental medwatch will be sent.The device history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.Attempts are being made to retrieve the device.To date, no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure, the trocar was shifting after inserting and removing devices in the 2cb12lt.Surgeon had to put finger in to offset the inner seal in order to fit stapler in trocar (not ideal as its supposed to be a smooth insert/removal process).To be noted it was a little better once the surgeon had the patient head up more but still an issue.Pressure was set to twelve which is the norm for him.There was no delay to procedure and there was no patient consequence.
Additional Manufacturer Narrative
(b)(4) date sent: 3/3/2022 d4: batch # unk h2: additional information received: a video was received for review.After analysis of the provided video, the 2cb12lt device was observed with the ring out of position, making it tough to insert a device though the trocar, however, no damage to the seal could be observed.Based on the video review, the event described was confirmed.Unfortunately, the video does not provide enough evidence to determine the root cause.The device was also received for investigation/analysis.Analysis of a physical device could potentially provide information needed to determine root cause.Investigation is anticipated, but not yet begun.Upon completion of investigation, a supplemental medwatch will be sent.As part of our quality process, all devices are manufactured, inspected and released to approved specifications.Additional complaint information is tracked for potential safety signals through complaint trending as part of post-market surveillance." a manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.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.
Additional Manufacturer Narrative
(b)(4) date sent: 3/22/2022.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the 2cb12lt was returned with no damage in the external components.In an attempt to replicate the reported incident, the devices were functionally tested to detect any compatibility issue and visually tested to detect any seal issues.Upon evaluation of the devices, a test instrument was inserted and no issues were noted related to an abnormal drag force.The device was disassembled in order to evaluate the condition of the seal.Upon disassembling, no anomalies were found.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.

• Brand Name: OPT SLEEVE 12X100 STABILITY
• 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
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13640545
• Report Number: 3005075853-2022-01246
• Device Sequence Number: 5201678
• Product Code: GCJ
• UDI-Device Identifier: 10705036014263
• UDI-Public: 10705036014263
• Combination Product (Y/N): N
• PMA/510(K) Number: K122512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2022

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: 06/30/2024
• Device Model Number: 2CB12LT
• Device Catalogue Number: 2CB12LT
• Device Lot Number: 367A86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 03/01/2022; 03/01/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown