MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ILA; STAPLE, IMPLANTABLE

Model Number	3948L
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/27/2018
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 a distal gastrectomy, they set the anvil to the anvil fork, and the surgeon clamped the duodenum and tried to fire the device, however, the knife did not advance.Replaced by a new reload, and the firing was completed.Reoperation was required due to the issue.The surgical time was extended by less than 30 min.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The loading unit was received partially fired with no visual abnormalities.The single-use loading unit (sulu) was loaded into a pmv representative instrument.The sulu and representative device were applied to the appropriate test media with acceptable results.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur if the firing stroke is not complete and the firing knob is not fully retracted after firing or if the instrument is applied against an excessive amount of tissue during the clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ILA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7805213
• Report Number: 2647580-2018-04161
• Device Sequence Number: 16407224
• Product Code: GDW
• UDI-Device Identifier: 10884521063150
• UDI-Public: 10884521063150
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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 Expiration Date: 10/31/2022
• Device Model Number: 3948L
• Device Catalogue Number: 3948L
• Device Lot Number: P7K1727X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 08/03/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention