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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Attempts are being made to retrieve the device.To date, no additional information has been received and no device has been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during a gastric cancer surgery, after fired, noted that the device was broken into a few pieces.All parts were taken out from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/30/2021 d4: batch # u9412y h6: component code: mechanical (g04) investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined the flr01 device was received with the retractor torn.No conclusion could be reached regarding what may have caused the found condition.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following: "caution: this retractor should be used in patients with abdominal wall thicknesses greater than 4.0 cm.Do not use the retractor where the incision length is greater than 9.0 cm as loss of pneumoperitoneum may occur.When the iris seal is closed, avoid sharp instrument contact, such as scissors, scalpel, needles, etc.With the elastomeric membranes, as puncture or tearing may occur." as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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
• MDR Report Key: 12375730
• Report Number: 3005075853-2021-05022
• Device Sequence Number: 3939124
• Product Code: GCJ
• UDI-Device Identifier: 10705036001966
• UDI-Public: 10705036001966
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 04/30/2025
• Device Model Number: FLR01
• Device Catalogue Number: FLR01
• Device Lot Number: U40G0J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1