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

Catalog Number	2B12LT
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 7/23/2024.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.D4: batch # c9de7h.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 the 2b12lt devices was returned inside it's package unopened with no apparent damage.The device was visually inspected and no damaged found on the obturator shaft.The device was fully functional according to the manufacturing requirements.The event described could not be confirmed as the device was returned without any damaged.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, it was found that the obturator shaft was broken.Changed to a new device to complete surgery.There was no patient consequence reported.No additional information can be provided.

• Brand Name: OPT BLADELESS 12X100 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 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19810263
• Report Number: 3005075853-2024-05344
• Device Sequence Number: 8348524
• Product Code: GCJ
• UDI-Device Identifier: 10705036014218
• UDI-Public: 10705036014218
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/23/2024

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 Catalogue Number: 2B12LT
• Device Lot Number: 854C59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown