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

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	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there are 3 jj55b cartridges, one is seal packed, the other is open but staple retaining cap is still there, the 3rd the safety lock was broken, there was an alignment problem as the cartridges were not fitting/aligning properly in the cartridge fork (not getting fit into the fork).There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch#: 444a14.Additional information: they opened the first, it was not fitting in the cartridge jaw.They tried forcedly putting it, but it was still not getting fit, then they tried another one and it had the same issue (one with retaining cap), so they didn¿t open the 3rd one and its seal packed (same lot).On visual inspection, one has the small lock at the proximal end of cartridge broken, most of the pins seems intact in cartridge.Second one had the retaining cap on and was not used.Third was in complete packing.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 inside of its opened 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 batch number, 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 ; * 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: 15877447
• Report Number: 3005075853-2022-08195
• Device Sequence Number: 14814164
• Product Code: GDW
• UDI-Device Identifier: 10705036002239
• UDI-Public: 10705036002239
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2022

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: 11/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown