MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*PROBE PLUS II HANDLE; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	EPH02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that there was a contamination issue.The plastic package was open.No patient consequence reported.
Additional Manufacturer Narrative
(b)(4).Investigation summary: the analysis results found that an eph02 device was returned outside its original package.Only the tyvek was returned for analysis.Upon visual inspection of the tyvek, it was observed that a piece of blister was broken and still adhered to the tyvek.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.The lot and batch history records were reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.

• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7183568
• Report Number: 3005075853-2018-07250
• Device Sequence Number: 1067338
• Product Code: GCJ
• UDI-Device Identifier: 20705036012440
• UDI-Public: 20705036012440
• Combination Product (Y/N): N
• PMA/510(K) Number: K912492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: EPH02
• Device Lot Number: P9242M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Initial Date Received by Manufacturer: 12/17/2017
• Supplement Date Received by Manufacturer: 12/17/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1