MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. DEXTRUS SMALL ACCESS RETRACTOR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	FLR01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p9253k.Per photographic evaluation: upon visual inspection of the picture, two devices are present in the photograph, both devices appear to have been torn.Refer to physical analysis for details on investigation.Device analysis: the analysis results of the flr01 found that it was received with the retractor torn.The tear initiated 2 inches below the upper retractor ring and continued toward the lower retractor ring, causing the separation from the ring.No conclusion could be reached as to what may have caused the found condition.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.,a picture of the sample was received for analysis.The batch history record was reviewed and identified a scratches, nicks, or blemishes defect related to the reported incident were found.When this occurs, our quality system documents the necessary actions to ensure final product quality.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.The final quality release criteria were met before this batch was released for distribution.
Event or Problem Description
Seal broken.Opened the packing, before used on patient, found the seal broken.Another like product was used to complete the procedure.There is no report on the patient's injury.

• Brand Name: DEXTRUS SMALL ACCESS RETRACTOR
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7072640
• Report Number: 3005075853-2017-06360
• Device Sequence Number: 10994803
• Product Code: GCJ
• UDI-Device Identifier: 20705036001963
• UDI-Public: 20705036001963
• Combination Product (Y/N): N
• PMA/510(K) Number: K070198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: 04/30/2019
• Device Catalogue Number: FLR01
• Device Lot Number: P4RH9Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR