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

Model Number	FLR02
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
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.No lot or batch number was provided therefore a device history could not be done.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide more details, did a piece or pieces fall into the patient? if yes, were they retrieved? if yes, are they being returned with the device? if not, were they disposed of?.
Event or Problem Description
It was reported that during an unknown procedure, the plastic separated.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 6/23/2022.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the flr01 device was received with the retractor torn inside it's original packaging opened.However, it could not be determined what may have caused this condition.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: 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.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14488163
• Report Number: 3005075853-2022-03400
• Device Sequence Number: 17327318
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 06/30/2023
• Device Model Number: FLR02
• Device Catalogue Number: FLR01
• Device Lot Number: 398A36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown