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

Catalog Number	2H12LP
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic hernia repair, inner cylinder could not be removed after the trocar was inserted.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/17/2024.D4: batch # a9e34w.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that 2h12lp device was returned with the obturator inserted through the universal seal.Upon evaluation of the device had difficulties to unlatch the obturator from the universal seal.The obturator was disassembled and the obturator latch was found to be incorrect not allowing to unlatch properly from the universal seal.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• Brand Name: OPT BLUNT TIP 12X100 SMOOTH
• 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: 19125830
• Report Number: 3005075853-2024-02996
• Device Sequence Number: 7629193
• Product Code: GCJ
• UDI-Device Identifier: 10705036014256
• UDI-Public: 10705036014256
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 2H12LP
• Device Lot Number: 677C50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown