MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LINEAR CUTTER/STAPLER-STANDARD; STAPLE, IMPLANTABLE

Model Number	JJ55B
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 field as appropriate.
Event or Problem Description
It was reported that they opened the packing, and it was noted that the jj55b reloads do not have safety-lock-out.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 02/24/2023.D4: batch # 444a14.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample determined that one jj55b reload was received inside of its unopened packaging.During the visual inspection of reload was noted that the reload belongs to a tcr55.However, the printed batch on reload was reviewed and it belongs to product code jj55b.Additional investigation of the returned lot number on the tyvek indicated that a tcr55 reload was packaged as a jj55b based on the batch number printed on the reload.The mix observed is potentially related to a manufacturing process.A manufacturing record evaluation was performed for the finished device lot number 459a28, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 444a14 , and no non-conformances were identified.

• Brand Name: LINEAR CUTTER/STAPLER-STANDARD
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 16252668
• Report Number: 3005075853-2023-00577
• Device Sequence Number: 5273519
• Product Code: GDW
• UDI-Device Identifier: 10705036002239
• UDI-Public: 10705036002239
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/27/2023

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 Expiration Date: 08/31/2026
• Device Model Number: JJ55B
• Device Catalogue Number: JJ55B
• Device Lot Number: 459A28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown