MAUDE Adverse Event Report: STANDARD BARIATRICS TITAN KIT SALES ASSEMBLY; SURGICAL STAPLER WITH STAPLE

Catalog Number	SGS23KIT
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "pusher bars did not push up staples.No staples fired on specimen side".Additional information states that the procedure was completed with another stapler.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "pusher bars did not push up staples.No staples fired on specimen side".Additional informaiton states that the procedure was completed with another stapler.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of "device - staple line incomplete" could be confirmed based on the returned sample and the customer photos.The customer returned one unit of sgs23kit titan kit sales assembly for investigation.The customer returned the titan standard gastric stapler, 19mm introducer sheath, and the standard staple-line reinforcement.The jaws were opened, and it was observed that the drivers failed to be pushed up by the sled on one side of the lower jaw.The jaws were disassembled to observe the underside of the cartridge.Half of the sled was found under the cartridge between the proximal and distal ends of the jaws.The sled wing was observed to be torn from the midsection of the sled resulting in the drivers failing to engage on one side.The drivers were initially engaged at the distal end of both sides, indicating that the sled wing tore during use.The sled wing was observed to be torn from the midsection of the sled resulting in the drivers failing to engage on one side.The supplier responsible for the assembly process was notified of the complaint investigation details.Nissha, the supplier, opened complaint investigation to evaluate the reported issue.As a result, nissha's supplier, atalys opened corrective action request.Visual and dimensional inspections with the available n issha medical technology lot, lot # 240222b-c.5 sled samples were audited.No cracking, separation of material, damage or evidence of stress were noted on any of the samples audited.All dimensions meet the drawing requirements were confirmed to meet the drawing requirements.Atalys ottoville llc was notified of the teleflex complaint.The corrective action request was initiated.Atalys reviewed their molding process, assembly process, and workorders.The workorders applicable to the runtime of the lot were confirmed to have no recorded rejects tied to the sleds.Additionally, the supplier confirmed 100% visual inspections are conducted at each part of the process.Therefore, nissha and atalys completed their evaluations and were unable to conclusively determine the root cause for the broken sled.This was determined to be an isolated incident.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: TITAN KIT SALES ASSEMBLY
• Common Device Name: SURGICAL STAPLER WITH STAPLE
• Manufacturer (Section D): STANDARD BARIATRICS; cincinnati OH
• Manufacturer (Section G): STANDARD BARIATRICS; 4300 glendale milford rd.; cincinnati OH 45242
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22012607
• Report Number: 3012481535-2025-00003
• Device Sequence Number: 12733585
• Product Code: GDW
• UDI-Device Identifier: 14026704923523
• UDI-Public: (01)14026704923523(11)250220(17)251222(10)36B2500002(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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
• Device Expiration Date: 12/22/2025
• Device Catalogue Number: SGS23KIT
• Device Lot Number: 36B2500002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown