MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO CLINCH* II 5MM INSTRUMENT; FORCEPS, OBSTETRICAL

Model Number 174317

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since the lot number was not provided, this information cannot be determined.Evaluation summary: post market vigilance (pmv) with engineering led an evaluation of one received one device opened by the account.The 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.Engineering noted that the housing appeared to be partially split where the shaft meets the handle.The unit was disassembled for evaluation.Proper welding was observed: all energy directors were properly melted.Brownish particles were observed adhered to the center rod, which prevented the center rod to have a free movement transition during actuation.Thus affecting opening/closing of jaws during application.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.A review of the 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 medtronic quality release specifications at the time of manufacture.Replication of the reported condition may occur when some type of fluid solidifies inside the center rod thus causing the needle to get stuck during deployment.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

According to the reporter, during surgery, the handle could not be squeezed anymore.The event occurred in use for patient.The procedure was completed with another device.The status of the patient: no problem.The patient gender is not available.The patient age is not available.The patient weight is not available.The device was not reprocessed/re-sterilized prior to use.

• Type of Device: FORCEPS, OBSTETRICAL
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6361212
• MDR Text Key: 68413976
• Report Number: 2647580-2017-00190
• Device Sequence Number: 1
• Product Code: HAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K903205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1