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

Model Number	FLR02
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during the endoscopic hand-assisted gastric cancer, before used on the patient, packaging was not opened however it was noted that the inner packaging (sterile packaging) was damaged.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: 7/30/2020.D4: batch # t40r5z.Investigation summary the analysis results found that a flr02 device was returned inside the sterile package without apparent damage.Upon visual inspection, no damage was noted on the packaging.The event could not be confirmed as no damage was noted on the packaging.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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
• MDR Report Key: 10237586
• Report Number: 3005075853-2020-03381
• Device Sequence Number: 13596648
• Product Code: GCJ
• UDI-Device Identifier: 10705036001973
• UDI-Public: 10705036001973
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K070198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2020

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: FLR02
• Device Catalogue Number: FLR02
• Device Lot Number: T40R5Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/14/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/30/2020
• Patient Sequence Number: 1