MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON ENDO GIA ADAPTER XL; STAPLE, IMPLANTABLE

Model Number EGIAADAPTXL

Device Problems Break (1069); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure type: sleeve gastrectomy.According to the reporter: the patient requires a great deal of torque.A crack was heard.The instrument snapped where adapter connects to reload.The instrument was not on tissue, but was through the trocar.The reload was still attached.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.No reinforcement material was used.There was no harm to patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one adapter and one reload opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned devices.No visual abnormalities were noted for the adapter.The eeprom was uploaded and indicated 6 autoclave cycles for the adapter.Visual examination of the staple cartridge noted that the reload had a full complement of staples.The proximal end of the adapter was broken and the articulation flag was bent.Functionally, the unload button on the adapter was depressed numerous times and displayed no hang-ups or sluggish returns.The isi pin location was checked and found to be at the center and the center rod orientation was checked and was found to be assembled properly.Since the clinical battery and handle were not returned, pmv representative ones were utilized for all functional testing.The adapter was inserted onto the handle and calibrated without issue.All five white status lights illuminated indicating more than 15 surgeries remaining on the adapter.Functional testing of the returned reload could not be performed due to the damage to the adapter and articulation rod.A pmv reload was inserted onto the adapter and the reload detect led immediately started flashing as intended, indicating that the software recognized the presence of a reload.The reload was closed and then opened to change the flashing green reload detect led to a solid green state.The adapter was rotated clockwise in increments of forty-five degrees and fully articulated left and right each time to detect an out of round sulu load ring but the reload detect led did not turn off indicating that the software recognized the presence of a reload the entire time.The pmv reload was then fired.The reload cut cleanly on the appropriate test media.The reload loaded, unloaded, articulated, rotated, and opened/closed properly and without difficulty.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the broken reload adapter and the reported conditions were confirmed.A review of the endo gia adapter device history record indicates this device lot number was released meeting all covidien quality release specifications at the time of manufacture.A review of the reload device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all covidien quality release specifications at the time of manufacture.Subsequently the complaint data did not display an increased trend.Replication of the damaged reload adapter may occur due to over flexure of the reload while attached to the instrument.No product improvements were generated for the reported condition.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: ENDO GIA ADAPTER XL
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 2034925267
• MDR Report Key: 4973034
• MDR Text Key: 23855685
• Report Number: 1219930-2015-00717
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 07/13/2015

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 Operator: Health Professional
• Device Model Number: EGIAADAPTXL
• Device Catalogue Number: EGIAADAPTXL
• Device Lot Number: N5D0233LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1