MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number 2B5LT

Device Problems Crack (1135); Use of Device Problem (1670)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 10/3/2023.D4: batch # unk.Additional information was requested and the following was obtained: "please provide more details about ¿became stuck on the end of the trocar sleeve, causing damage¿ they were unsure how damage could have occurred such as through residual heat from the l hook or if the l hook was accidentally activated during removal.The l hook itself appeared to be damaged / bent prior to the issue with the trocar per the surgical team.Did the trocar sleeve break off in patient? it did not appear that anything broke off." investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that only the sleeve from the 2b5lt device was received with the tip of the sleeve damaged melted.The event reported was confirmed and it is related to improper use of the device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.The manufacturing records couldn't be reviewed as the batch number is unknown.

Event Description

It was reported that during a laparoscopic cholecystectomy, when removing the laparoscopic monopolar l hook it became stuck on the end of the trocar sleeve, causing damage.It was later noted that the l hook was bent prior to getting stuck on the trocar.No delays.Procedure was completed.No patient harm.

• Brand Name: OPT BLADELESS 5X100 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 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17861124
• MDR Text Key: 324802578
• Report Number: 3005075853-2023-07121
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: 10705036013709
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2023

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 Catalogue Number: 2B5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1