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

Model Number	FLR01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hand assisted laparoscopic partial colectomy, the clear retraction portion was coming off of the ring.A new device was used to complete the case with no patient consequences.
Additional Manufacturer Narrative
(b)(4).Batch # unk.Additional information was requested and the following was obtained: "rep stated the correct product code is either flr01 or flr02 - the dextrus fixed-length access retractor.The rep was unable to provide the exact code." 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 will be sent.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16371791
• Report Number: 3005075853-2023-00962
• Device Sequence Number: 12465907
• Product Code: GCJ
• UDI-Device Identifier: 10705036001966
• UDI-Public: 10705036001966
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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 Model Number: FLR01
• Device Catalogue Number: FLR01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown