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

Model Number 174317

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Patient information not provided. Udi not provided. Re-processing information not provided.

Event Description

According to the reporter, during a lobectomy, when lung parenchyma was set and released with the device, the root of jaws was broken. The device did not work. There were no operations which became a burden to the device. The procedure was completed with another device. The product was removed from the tissue without damaging it.

Manufacturer Narrative

(b)(4). Post market vigilance (pmv) led an evaluation of one endo clinch. 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, and an evaluation of the returned device. The visual inspection of the device noted the jaws were broken. The shaft snapped just proximal to the jaws. Engineering found that the tube housing was broken on both tabs; jaws were still attached to the rivet of the broken tabs. The rivet was inspected and it was found properly riveted. Replication of the broken jaws may occur when excessive manipulation of side force (leverage) by user consequently causes the breakage of the tube housing tabs. The riveted tabs hold in place the jaws; once the tube housing is broken the jaws could become loose. The file will be closed as misuse of the product. Should new information become available, the file will be re-opened and reassessed at that time.

• 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: 5820142
• MDR Text Key: 50349400
• Report Number: 2647580-2016-00521
• 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

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2020
• Device Model Number: 174317
• Device Catalogue Number: 174317
• Device Lot Number: P5L0024X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown