MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC ENDO DISSECT* 5MM INSTRUMENT; MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Model Number 176645

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

Tracking number: (b)(4).Device has not been received.A supplemental report will be sent if device is received.

Event Description

According to the reporter, it was noted that the tip of the device was not aligned.The device was not used.The udi number is not available.The event occurred during the procedure but the product was not used for patient.The status of the patient is fine.Additional tissue resection was not required.There was no tissue damage.The incision site was not extended.Nothing fell into the patient's cavity.The product did not lock on tissue and was removed from the tissue without damaging it.No bleeding occurred.The procedure was completed with another device.The surgical time was not extended.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.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device.The event report alleges the product was not used in a surgical procedure.Visual observation and measurement indicated the jaw alignment was in specification.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Type of Device: MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
• 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: 6180799
• MDR Text Key: 62683558
• Report Number: 2647580-2016-01101
• Device Sequence Number: 1
• Product Code: GET
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K904578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 176645
• Device Catalogue Number: 176645
• Device Lot Number: P6F0226X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1