MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE

Model Number	SIGMRET
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Sepsis (2067); Tachycardia (2095); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic gastric sleeve, after firing the second reload at the insicura angularis, the i-beam blade would not retract.Two manual retraction tools were used but after a few attempts the retraction tool broke and could not continue to retract the blade. soft reboot failed.Two allen keys were tried to no avail.The adapter and reload was difficult to unload so the adapter with reload was eventually pulled off from remnant stomach, causing tear on the tissue (insicura angularis).Laparoscopic stitching was required to repair the defect with an additional omental patch pexy.Perforation at staple line with gastric mucous contamination was oversewn.Surgical time was extended by 30 minutes.Second day postoperatively, the patient was septic, febrile and tachycardic.A computed tomography (ct) scan was ordered and hematoma forming was found.On day 6, the patient severe upper quadrant pain so a repeat ct scan was performed.On day 7, the patient had laparoscopic drainage of intra-abdominal abscesses, washout and two drains were placed.The patient was given intravenous antibiotics and antifungals.The patient required a week in hospital.The same handle worked fine with another reload and adapter.

• Brand Name: SIGNIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14647027
• Report Number: 1219930-2022-02166
• Device Sequence Number: 14892140
• Product Code: GDW
• UDI-Device Identifier: 10884521543881
• UDI-Public: 10884521543881
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160176
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIGMRET
• Device Catalogue Number: SIGMRET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 06/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 101 KG