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	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # t92e7w.Investigation summary: the analysis results found that the hap02 device was received with the iris seal torn, 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
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.Attempts have been made to retrieve the following additional information and the device: please clarify the event: hap02 tip torn off.Did the seal tear ? did any pieces fall into the patient? if yes: how were the pieces retrieved? was there any patient consequence? if yes: please explain.How was the patient consequence resolved? how was the procedure completed? to date, no additional information has been provided and the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that during an unknown procedure, hap02 tip has torn off.It is unknown how procedure was completed.Patient consequence was not reported.

• 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: 9242323
• Report Number: 3005075853-2019-23000
• Device Sequence Number: 11180318
• Product Code: GCJ
• UDI-Device Identifier: 10705036002055
• UDI-Public: 10705036002055
• 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): 09/26/2019

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: 01/15/2021
• Device Catalogue Number: HAP02
• Device Lot Number: T92H9N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/13/2019
• Patient Sequence Number: 1