MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	5552002
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nd (nezhat dorset) handle has qd (quick disconnect adapter), that allows for the tubing set to be switched from right/left-handed operation.The probe tip is then seated onto the qd adapter.The subject product evaluation found the qd adapter had unscrewed from the nezhat dorsey handle as was initially reported and remained seated on the probe tip.The qd adapter was removed from the probe tip, screwed back into the nd handle body, manually tightened, and the probe tip was reattached with no issue.The adapter and probe tip both stayed in place and did not loosen.Both the qd adapter and probe tip were in good condition, with no manufacturing anomalies noted.Although it cannot be determined how the qd adapter became unscrewed during use at this time, it is possible the qd adapter unscrewed due to an event occurring during user/device interface.The ifu instructions include: "the scrub nurse retains the trumpet valve handpiece and checks and tightens the knurled quick disconnect adapter at the front of the trumpet valve." the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that an x-stream laparoscopic irrigation tubing set that was used during a laparoscopic cholecystectomy case on 12/27 had the tip screw out out of the suction tip during the case.In order to complete the case, the surgeon picked a new tubing set to use.It was later reported that the device physically broke where the attachment tip connects onto the nd quick disconnect adapter.Nothing had fallen into the patient, this was a laparoscopic case and the section of the device that detached was external.There was no injury or impact to the patient.

• Brand Name: X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9633694
• Report Number: 1213643-2020-00648
• Device Sequence Number: 502099
• Product Code: GCJ
• UDI-Device Identifier: 00801741010095
• UDI-Public: (01)00801741010095
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K003790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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: 09/28/2022
• Device Catalogue Number: 5552002
• Device Lot Number: JUDXF084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR