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

Catalog Number FLR02

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

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 Description

Pulled it lightly, but tear.There were no patient consequences.

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
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7586198
• MDR Text Key: 111156578
• Report Number: 3005075853-2018-10465
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036001970
• UDI-Public: 20705036001970
• Combination Product (y/n): N
• PMA/PMN Number: K070198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1