MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LINEAR CUTTER/STAPLER-STANDARD; SURGICAL STAPLE LOADING UNIT, NON-CUTTING

Model Number	JJ55B
Medical Device Problem Codes	Difficult to Insert (1316); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).Batch # 444a14.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that one jj55b reload was received sterile with no apparent damage.During the visual inspection of reload inside of the unopened package was noted that the reload belongs to a tcr55.However, the printed batch on reload was reviewed and it belongs to product code jj55b.The mix observed is potentially related to a manufacturing process.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that after opening the packing, the surgeon noted that it is very difficult to install the cartridge.Carefully checked the reload, the operator found the reload appearance was different with the normal ones, which did not have safety lock.There was no safety-lock on both sides of the reload.No photos available.Changed to another device to complete the procedure.There was no patient consequence reported.No additional information could be provided.Procedure: unknown.

• Brand Name: LINEAR CUTTER/STAPLER-STANDARD
• Common Device Name: SURGICAL STAPLE LOADING UNIT, NON-CUTTING
• 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: 15787932
• Report Number: 3005075853-2022-07853
• Device Sequence Number: 12130447
• 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
• Report Date (Section B): 11/14/2022

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
• Date Returned to Manufacturer: 10/26/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 11/14/2022
• 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: Male