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

Model Number 174317

Device Problem Break (1069)

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

Event Date 09/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the device broke after the surgeon closed and opened the device a few times.Udi number is not available.The event occurred in use for patient.The procedure was completed with another device.The surgical time was not extended.The status of the patient: no problem.Additional tissue resection is 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.Female patient 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

(b)(4).Evaluation summary: post market vigilance (pmv) concurrently with engineering led an evaluation of one device opened by the account and one photograph.The visual inspection of the device and photograph noted that the instrument was received broken in pieces.There was evidence of material transfer on both halves of the device.Replication of the observed damage may occur as a result of rough handling.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• 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: 6066242
• MDR Text Key: 58747520
• Report Number: 2647580-2016-00885
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• 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: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• 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: Initial
• Patient Sequence Number: 1