MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*5MM GRASPER; GRASPER 5MM

Catalog Number	5DSG
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r93n8n.Device analysis: the analysis results found that a device was returned outside its original package.Only the tyvek was returned for analysis.Upon visual inspection of the device, the foreign body was confirmed to be a hair and taped to the device.Although no conclusion could be reached on how the hair was introduced inside the sterile package, it is possible that the hair adhered to the device during the packaging process due to static.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during an unknown procedure, a foreign matter like a hair was found in the package when the package was opened.The device was not used for the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• Common Device Name: GRASPER 5MM
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8060525
• Report Number: 3005075853-2018-14334
• Device Sequence Number: 215558
• Product Code: MDM
• UDI-Device Identifier: 10705036000792
• UDI-Public: 10705036000792
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: 05/31/2023
• Device Catalogue Number: 5DSG
• Device Lot Number: R40M1P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/12/2018
• Patient Sequence Number: 1