MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	2B5LT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 confirm was the hold on the tyvek? if yes, did it compromise the device sterility? if not, was it a different portion of the device packaging? 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 an unknown procedure that there was a packaging issue.There was a hole in the plastic.Like devices were used to continue with the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4) date sent: 7/19/2022 investigation summary the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample revealed that the 2b5lt device was returned inside its package opened with no damaged; upon visual inspection, the seal area was inspected and evidence of being properly sealed was found in the package.In addition, no holes were observed in the tyvek.As part of our quality process, the manufacturing records of this lot number were reviewed, and the manufacturing standards were met prior to the release of this lot.All ethicon product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.Although no conclusion could be reach on the cause of the reported event as per conditions of the returned packaging.

• Brand Name: OPT BLADELESS 5X100 STABILITY
• 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: 14803198
• Report Number: 3005075853-2022-04142
• Device Sequence Number: 4653519
• Product Code: GCJ
• UDI-Device Identifier: 10705036013709
• UDI-Public: 10705036013709
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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: 07/31/2026
• Device Model Number: 2B5LT
• Device Catalogue Number: 2B5LT
• Device Lot Number: 412A89
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown