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

Model Number	2D12LT
Medical Device Problem Codes	Crack (1135); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during to an unknown procedure, the trocar when used fall apart.The surgery was delayed by 15 minutes but was completed successfully.There were fragments outside of the patient but it did not require any intervention.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch: # unk.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.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.Additional information was requested and the following was obtained: what is meant by ¿when used they fell apart¿? it splits when the shirt is worn was the damaged identified during use or right out of the package? no.Were the devices re-sterilized or were they opened directly out of the sterile pouch from the manufacture? i believe re-sterilized, they do not give lot information.How was the surgery completed? yes.Were pieces of the trocar left within the patient¿s abdomen? none.If so, how were those fragments generated during the procedure? what type of intervention was performed to remove the fragments from the patient? does not apply.Was the patient¿s post-op care altered in any way due to the reported complication with the trocar? no.What is the current status of the patient? sure.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: 9/22/2022.D4: batch # unk.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 2d12lt device was returned with the housing cap component disassembled from the housing of the sleeve assembly.The housing cap and the housing are damaged.It should be noted that product failure is multifactorial.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon¿s quality system.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 and lot number are unknown.

• Brand Name: OPT DILATING 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 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15245479
• Report Number: 3005075853-2022-05378
• Device Sequence Number: 6355525
• Product Code: GCJ
• UDI-Device Identifier: 10705036014232
• UDI-Public: 10705036014232
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 09/22/2022

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 Model Number: 2D12LT
• Device Catalogue Number: 2D12LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown