MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ANVIL GRASPER W/RATCHET HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	10AG
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the tip of the device could not clamp the target tissue.Another device was used to complete the case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/28/2023.D4: batch # unk.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: 7/26/2023.D4: batch # x94l0f.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 determined that the 10ag device was received with the cam ratchet button disassembled and the end effector damaged.In addition, the cam ratchet button was returned inside a plastic bag.In an attempt to replicate the reported incident, the device was tested for functionality to evaluate any end effector issues.Upon functional testing the end effector could not open.The device was disassembled in order to evaluate the condition of the internal components and the cam ratchet button was confirmed to be broken.Although no conclusion could be reach on the cause of the reported event.The reported complaint was confirmed.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.

• Brand Name: ANVIL GRASPER W/RATCHET HANDLE
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17216456
• Report Number: 3005075853-2023-04475
• Device Sequence Number: 2985647
• Product Code: MDM
• UDI-Device Identifier: 10705036000365
• UDI-Public: 10705036000365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 07/26/2023

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: 10AG
• Device Catalogue Number: 10AG
• Device Lot Number: X94L0F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown