MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT DILATING 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	2D5LT
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Unknown, assumed 1st day of month that complaint was reported.Batch #: unknown.As a lot/batch was not provided, a device history could not be performed.(b)(6).

• Brand Name: OPT DILATING 5X100 STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7491652
• Report Number: 3005075853-2018-09599
• Device Sequence Number: 1677582
• Product Code: GCJ
• UDI-Device Identifier: 20705036013751
• UDI-Public: 20705036013751
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 2D5LT
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1