MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X100MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number 2CB5LT

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/04/2022

Event Type  malfunction  

Event Description

It was reported during a cholecystectomy the ethicon xcel 5mm trocar was "sticking".There were no patient consequences.

Manufacturer Narrative

(b)4).A photo was submitted to ethicon endo surgery for review along with the device sample.During the visual analysis of the photo, the following was observed: the photo shows a trocar with a broken sleeve, with a device inserted.Visual analysis of the returned sample determined that the 2cb5lt device was received with the tip of the sleeve damaged melted.No sticking was observed during the analysis.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.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.No further investigation will be conducted on this complaint due to external cause.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: OPT SLEEVE 5X100MM STABILITY
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; *
• MDR Report Key: 14013837
• MDR Text Key: 288671081
• Report Number: 3005075853-2022-02055
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036013730
• UDI-Public: 10705036013730
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2022

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
• Device Operator: Health Professional
• Device Model Number: 2CB5LT
• Device Catalogue Number: 2CB5LT
• Device Lot Number: 409A59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1