MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO MINI-SHEARS* 5MM INSTRUMENT; LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Model Number	174301
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during a laparoscopic hernia procedure, the tip of the blades of the device did not meet.This occurred inside the patient.To correct the condition, another device was used.No other known adverse events were reported.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) and engineering led an evaluation of one device 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, an engineering evaluation, and an evaluation of the returned device.The jaws opened and closed without any hang ups noted.The jaws failed to cut the appropriate test media.Upon close analysis of the blades engineering noted that only the tip met during actuation.There was a significant gap between the proximal to the tip of the blades.Engineering also noted a bent blade.The bent blade assembly can be replicated by pushing the assembly against a hard surface.Visual testing of the returned product confirmed the product did not meet quality release specifications that were tested regarding the reported conditions due to the damaged blade.Replication of the bent blade assembly can be replicated by pushing the assembly against a hard surface.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.Based on the product analysis, the failure was confirmed to be attributed to the reported event.The file will be closed as a misuse of the product.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Common Device Name: LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• MDR Report Key: 5842774
• Report Number: 2647580-2016-00546
• Device Sequence Number: 266924
• Product Code: HET
• UDI-Device Identifier: 10884523000672
• UDI-Public: (01)10884523000672(17)201031(10)P5K0743X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K903206
• 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,Followup
• Report Date (Section B): 07/13/2016

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: 10/31/2020
• Device Model Number: 174301
• Device Catalogue Number: 174301
• Device Lot Number: P5K0743X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/13/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 08/24/2016; 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1