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

Model Number	2D5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information received: two photos were received for review.During the visual analysis, the following was observed: the first photo shows a trocar with the sleeve broken off.The second photos shows the tyvek of the bladeless device.Based on the set of photos reviewed, the event described is 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.See the device analysis below.More additional information received: how was the trocar broken during insertion in the abdomen? from the middle while inserting.Was the entire trocar removed? was just broken.Does surgeon believe a piece of the trocar remains in patient? no.Investigation summary: upon visual analysis of the returned sample, it was determined the sleeve from the 2d5lt device was received with the sleeve broken.In addition, the broken part from the sleeve was returned inside of a plastic bag.No conclusion could be reached regarding what may have caused the reported incident.One possible cause for the damage found may be due to excessive force being applied to the device.Please refer to the instructions for use for additional information regarding proper device usage.Additional complaint information monitoring for potential safety signals will be conducted 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.
Event or Problem Description
It was reported that during an unknown procedure, the trocar was broken from the middle during insertion into the abdomen.No pieces remain in the patient.It is unknown how the procedure was completed.There was no patient consequence.

• Brand Name: OPT DILATING 5X100 STABILITY
• Common Device Name: 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 13564042
• Report Number: 3005075853-2022-00958
• Device Sequence Number: 20292218
• Product Code: GCJ
• UDI-Device Identifier: 10705036013754
• UDI-Public: 10705036013754
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• 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
• Report Date (Section B): 02/18/2022

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: 05/31/2026
• Device Model Number: 2D5LT
• Device Catalogue Number: 2D5LT
• Device Lot Number: 347A05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown