MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH EXCEL; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B5LT

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Manufacturer Narrative

(b)(4).Batch # unk.The analysis results found that the b5lt instrument was received with the sleeve broken and melted.In addition, the tyvek was returned for analysis.This type of damage is consistent with the one produced by an energized device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.

• Brand Name: ENDOPATH EXCEL
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6561974
• MDR Text Key: 75162547
• Report Number: 3005075853-2017-02529
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: B5LT
• Device Lot Number: P4R25U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1