MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. DEXTRUS SEAL CAP ASSEMBLY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number	HAP02
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Per photographic evaluation: upon visual inspection of the pictures, it appears the dextrus device to be torn.In the other photo the packaging boxes are shown.No definitive conclusion could be reached as to the origin of the damage as the device was not returned for analysis.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
Device breakage.During the unknown surgery, before used on the patient, opened the packing, found the seal was broken.Another device was used to complete the surgery.There were no adverse consequences to the patient.Our customer suspect if the seal was sticky to the plastic packing results the seal broken.
Additional Manufacturer Narrative
(b)(4).Batch # p9299e device analysis: the analysis results found that the hap02 device was received with the iris seal torn.In addition, the tyvek was returned along with the instrument.The initiation site appeared to be adjacent to the o-ring and migrated approximately 270º around on the upper inner seal ring, and then it propagated toward the lower seal ring.However, it could not be determined what may have caused this condition.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: DEXTRUS SEAL CAP ASSEMBLY
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7292601
• Report Number: 3005075853-2018-08157
• Device Sequence Number: 14047983
• Product Code: GCJ
• UDI-Device Identifier: 20705036002052
• UDI-Public: 20705036002052
• 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): 01/30/2018

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: 04/30/2019
• Device Catalogue Number: HAP02
• Device Lot Number: P92F37
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1