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

Model Number	FLR02
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, the device broke immediately after opening.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/31/2023.Unknown, assumed first day of month that complaint was reported.Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested and the following was obtained: "there was no effect on the patient the payment was torn, the retractor completely out of the ring area" "was the retractor seal torn? - the seal was torn, the retractor completely left the ring area was difficult to open or closed seal assembly? - the manager didn't not understand this question were there any patient consequences? if yes, please describe.- there was no effect on the patient if available, please confirm the event date - no information" 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.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 MED 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: 17032261
• Report Number: 3005075853-2023-03619
• Device Sequence Number: 12376830
• Product Code: GCJ
• UDI-Device Identifier: 10705036001973
• UDI-Public: 10705036001973
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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 Expiration Date: 09/30/2023
• Device Model Number: FLR02
• Device Catalogue Number: FLR02
• Device Lot Number: 489A42
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown