MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. OPT SLEEVE 5X75MM STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number	2CB5ST
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #unk.Date of event is unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance 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 before an unknown procedure, a pinhole was found on the barcode on the wrapping paper.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/24/2020 investigation summary the analysis results found that 2cb5st device was returned inside its package unopened.Upon visual inspection, it was observed that the tyvek from the packaging was damaged.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage; it appears that the package hit a pointy surface and this caused the reported event.The reported complaint was confirmed.All ees product is 100% inspected prior to release.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• Brand Name: OPT SLEEVE 5X75MM STABILITY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10335695
• Report Number: 3005075853-2020-03859
• Device Sequence Number: 16958888
• Product Code: GCJ
• UDI-Device Identifier: 10705036013747
• UDI-Public: 10705036013747
• Combination Product (Y/N): N
• PMA/510(K) Number: K032676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 12/31/2024
• Device Model Number: 2CB5ST
• Device Catalogue Number: 2CB5ST
• Device Lot Number: U4010P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1