MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH ETS LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number ETS45

Device Problems Defective Component (2292); Misfire (2532); Fail-Safe Problem (2936)

Patient Problem Laceration(s) (1946)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.At the time of this submission, the device has not been returned for analysis.

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that only a photo for analysis was received.The picture shows two cartridge reloads, one cartridge in good visual condition and on the other cartridge the spring cartridge lockout tab is not visible.Since the reloads were not returned for analysis, no further evaluation could be performed.Event could not be confirmed, as the sample was not returned.A batch record review was performed and the batch had no anomalies noted during the manufacturing process.

• Brand Name: ENDOPATH ETS LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): DEFAULT ORGANIZATION; 4545 creek rd ml # 36; cincinnati OH 45242 280
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4054542
• MDR Text Key: 4731867
• Report Number: 3005075853-2014-06134
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K020779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Type of Report: Initial,Followup
• Report Date: 08/14/2014

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: ETS45
• Other Device ID Number: BATCH # UNK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR