MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PWRD ECH FLEX 45MM; STAPLE, IMPLANTABLE

Catalog Number PSE45A

Device Problems Break (1069); Scratched Material (3020); Torn Material (3024)

Patient Problems Nicks, cuts or tears of dura or other tissues by device (1417); Bleeding (1738)

Event Date 02/28/2014

Event Type  malfunction  

Event Description

It was reported that a vats lobectomy procedure, the consultant was trying to position the product before firing the product on a vessel.During the positioning, he feels that the product has torn one of the pa branches causing some bleeding.He then had to clamp that vessel and suture it to stop the bleeding.He believes that the product anvil was sharper than usual.The discarded the product.

Manufacturer Narrative

(b)(4).Device was not returned for evaluation.Additional information was requested and the following was obtained: how much blood was lost (ml)? 100 ml.Did the patient require a transfusion? no.Was the post-operative care for the patient changed as a result of this event? no.

• Brand Name: PWRD ECH FLEX 45MM
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3709448
• MDR Text Key: 4249416
• Report Number: 3005075853-2014-02021
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2014

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 Catalogue Number: PSE45A
• Device Lot Number: K4DL0E
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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