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 Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Additional 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 the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.
Event or Problem Description
It was reported that during a bowel procedure, the retractor device fell apart when in use by the surgeon, which was inconvenient for the surgeon and or staff.There were no patient consequences.No additional information is available at this time.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/12/2020 d4: batch # t94383 investigation summary the analysis results of the flr01 found that it was received with the retractor sheath separated from the upper retractor ring.No conclusion could be reached as to what may have caused the found condition.Although there is no direct evidence of use error, the instructions for use do 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." it should be noted that 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.

• 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: 10428259
• Report Number: 3005075853-2020-04218
• Device Sequence Number: 14003016
• Product Code: GCJ
• UDI-Device Identifier: 10705036001966
• UDI-Public: 10705036001966
• Combination Product (Y/N): N
• PMA/510(K) Number: K070198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: 07/31/2021
• Device Model Number: FLR01
• Device Catalogue Number: FLR01
• Device Lot Number: T40T5J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 11/12/2020
• Patient Sequence Number: 1