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

Model Number	2B5LT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the trocar disintegrated and went into the patient and had to be fished out.It is unknown how procedure was completed.Patient consequence was not reported.
Additional Manufacturer Narrative
(b)(4).Batch # 232a42.The lot/batch history records were reviewed and certified by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.Attempts are being made to obtain additional information and to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent: additional information requested: please confirm, were all trocar components retrieved from the patient? are all components available to be returned with the rest of the device? were there any patient consequences? if yes, please describe.

• Brand Name: OPT BLADELESS 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: 13052988
• Report Number: 3005075853-2021-08028
• Device Sequence Number: 1584646
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: 10705036013709
• 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): 12/21/2021

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: 03/31/2026
• Device Model Number: 2B5LT
• Device Catalogue Number: 2B5LT
• Device Lot Number: 232A42
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown