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

Catalog Number	FLR02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92k5y.Investigation summary: the analysis results of the flr02 found that it was received with the retractor torn.In addition, a plastic bag was returned with a piece of the retractor inside.No conclusion could be reached as to what may have caused the found condition.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Additional Manufacturer Narrative
(b)(4).Batch # t92k5y.Investigation summary: the analysis results of the flr02 found that it was received with the retractor torn.In addition, a plastic bag was returned with a piece of the retractor inside.No conclusion could be reached as to what may have caused the found condition.The reported complaint was confirmed.In addition, a photo was received for review.Upon visual inspection of a photo, the following was observed: the photo shows dextrus small access retractor from top view and the retractor can be seen torn.Based on the photo alone the event describe is confirmed, however no conclusion or root cause could be determined.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, while the surgeons hand was in the device and in the patient, there was a ¿pop¿ and a piece of the plastic had broken off and had to be retrieved from inside the patient.It is unknown how the procedure was completed.No patient consequences were reported.

• Brand Name: DEXTRUS MED 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: 8984767
• Report Number: 3005075853-2019-21890
• Device Sequence Number: 1825625
• Product Code: GCJ
• UDI-Device Identifier: 10705036001973
• UDI-Public: 10705036001973
• Combination Product (Y/N): N
• Initial Reporter State: AK
• PMA/510(K) Number: K070198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 02/28/2021
• Device Catalogue Number: FLR02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1