MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN EEA; STAPLE, IMPLANTABLE

Model Number HEM3335

Device Problems Detachment Of Device Component (1104); Failure to Cut (2587)

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

Event Date 04/21/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when they fired the stapler during hemorrhoidectomy, the cartridge pushed up and the staple fell on anus without the knife cutting the tissue.The staple was retrieved.It was also reported by the surgeon that the handle was loose and the surgeon felt that it will not work.A new device was used to complete the case.The procedure was extended for half an hour.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Post market vigilance (pmv) led an evaluation of one device.Visual inspection noted a disengaged staple guide.Further inspection noted material transfer between the two components in both the disengaged staple guide and instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EEA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7477295
• MDR Text Key: 107039367
• Report Number: 1219930-2018-02388
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521047515
• UDI-Public: 20884521047515
• Combination Product (y/n): N
• PMA/PMN Number: K083781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: HEM3335
• Device Catalogue Number: HEM3335
• Device Lot Number: N6G0728MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Date Manufacturer Received: 10/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR