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	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.As a lot/batch was not provided, a device history could not be performed.Additional information was requested and the following was obtained: what part of the device was torn, the iris value seal or the retractor sheath? did any pieces of the device fall into the patient? if yes, how were the pieces retrieved? was there any loss of pneumo due to the tear in the device? how was the procedure completed? was there any patient consequence? response: no further information available.
Event or Problem Description
Pulled it lightly, but tear.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # p9399w.Device analysis: the analysis results of the flr02 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.No conclusion could be reached as to what may have caused the found condition.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• 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: 7586198
• Report Number: 3005075853-2018-10465
• Device Sequence Number: 19181351
• Product Code: GCJ
• UDI-Device Identifier: 20705036001970
• UDI-Public: 20705036001970
• 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,Followup
• Report Date (Section B): 05/17/2018

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: 07/31/2019
• Device Catalogue Number: FLR02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1