MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC SGIA 60-3.8 SINGLE USE STAPLER; STAPLE, IMPLANTABLE

Model Number	SGIA6038S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	Pain (1994); Tissue Damage (2104); Injury (2348); Obstruction/Occlusion (2422)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(b)(6).
Event or Problem Description
According to the reporter, during a barcelona procedure the knifeless stapler used was mistaken for a cutting stapler due to similar packaging.A reoperation was performed after 12 days due to this error.There was an extension of the incision by more than 1 inch and unanticipated tissue loss.No reinforcement material was used.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received indicated that the patient condition is unknown at this time.As a result of the reported issue, the pouch caused an obstruction and had to be recreated.The issue was identified post-operatively, when the patient began to complain of pain.No further information is anticipated at this time.Should new information be received, a supplemental report will be submitted.

• Brand Name: SGIA 60-3.8 SINGLE USE STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• MDR Report Key: 5787654
• Report Number: 2647580-2016-00413
• Device Sequence Number: 16228746
• Product Code: GDW
• UDI-Device Identifier: 10884523007299
• UDI-Public: 0110884523007299
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K013860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2016

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: SGIA6038S
• Device Catalogue Number: SGIA6038S
• Device Lot Number: P4D0574KX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 09/12/2016
• 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; Disability