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).Batch # p9242m.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 tho 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: 7183560
• Report Number: 3005075853-2018-07249
• Device Sequence Number: 1340485
• 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): 12/18/2017

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: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• 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