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

Model Number UNKNOWN STAPLER

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

According to the reporter, during an open lung resection, when the stapler was fired across lung tissue, there was a poor staple formation.Staple load was removed; reinforcement was hanging off of the distal tip of the reload and seemed to be ¿bunched-up¿ at the end.One side of the stapled tissue area had staples, while the other did not.All of the buttress material remained on the reload after firing.The load was dipped in sterile water prior to firing per ifu.In order to complete the case and resolve the issue, suture was used to sew over the area where the stapler was fired.No patient injury was noted but the surgical time was extended to greater than 30 minutes to re-suture the area.

• Brand Name: UNKNOWN STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6891261
• MDR Text Key: 87457364
• Report Number: 1219930-2017-07380
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN STAPLER
• Device Catalogue Number: UNKNOWN STAPLER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1