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

Model Number	GIA6048S
Medical Device Problem Codes	Detachment Of Device Component (1104); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two photographs.The photographs indicate the firing knob was disengaged from the stapler.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of this condition may occur if an excessive upwards force is applied to the firing knob during disassembly, or if the knob is not fully rotated to one side prior to firing, causing detachment.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, a device had button fire decoupling.

• Brand Name: GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 7104407
• Report Number: 2647580-2017-08650
• Device Sequence Number: 19316206
• Product Code: GDW
• UDI-Device Identifier: 20884523007241
• UDI-Public: 20884523007241
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: GIA6048S
• Device Catalogue Number: GIA6048S
• Device Lot Number: P6E0244KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1