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

Model Number	FLR01
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	08/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: u94t5e.(b)(4).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 found that it was received with the retractor sheath separated from the upper retractor ring.In addition, no torn retractor was observed.No conclusion could be reached as to 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 not 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." as part of our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be 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.In addition, a photo was received for review.During the visual analysis, the following was observed: the photo showed a dextrus device inside its open packaging and the upper retractor ring can be seen separated from the retractor.Based on the photo review the event described is confirmed, however no conclusion or root cause could be determined.See hands on device analysis above.
Event or Problem Description
It was reported that during hals rectal surgery, opened the packing, noted the device was damaged.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• 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
• MDR Report Key: 12587014
• Report Number: 3005075853-2021-06016
• Device Sequence Number: 17120664
• 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
• Report Date (Section B): 09/27/2021

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: 07/01/2022
• Device Model Number: FLR01
• Device Catalogue Number: FLR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1