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

Model Number 174317

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a laparoscopic endometrial cancer extirpation, upon clamping fat of mesentery, the jaws fixed in the closing position, and did not open.Fat was resected to remove the device from the 5 mm port.No patient harm and tissue damage has been reported since the resected tissue was fat.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation 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 ratchet switch was disengaged.The rotation knob functioned without difficulty.The jaws were opened and closed, and grasped media without difficulty.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 quality release specifications at the time of manufacture.Replication of the secondary blades indicates that the instrument may have been exposed to an external force which bent the exposed metal bars.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: 5585054
• MDR Text Key: 42918343
• Report Number: 2647580-2016-00168
• 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,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/18/2016; 05/18/2016; 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention