MAUDE Adverse Event Report: STRYKER CORPORATION BERCHTOLD BOOM; TABLE, OPERATING-ROOM, AC-POWERED

Device Problems Decrease in Suction (1146); Kinked (1339); Leak/Splash (1354); Smoking (1585); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

Unable to provide product info.Reportable.Operative report: patient had signed consent for total laparoscopic hysterectomy; however, the smoke evacuator was not functioning well.The visualization was poor at the time of attempted colpotomy.Therefore, because of poor visualization, decision was made to complete the surgery vaginally, thereby the procedure was laparoscopic-assisted vaginal hysterectomy.Disposable smoke evacuator was not functioning well.On investigating this incident, it is important to point out that two of the three vacuum lines on the berchtold equipment boom in operating room are weak and have been problematic and reoccurring issues for many months.Several fixes have been performed but these vacuum lines have continued to provide weak suction and there is no fix at this point that can improve upon them.The problem lies in copper pipes servicing the medical gases above the ceiling level, including the vacuum, that terminate at the outlets mounted on the boom, which have become over time partially kinked and may even have sustained leaks due to over rotating of the equipment booms.The booms are not labeled with ce #s; only the individual pieces of equipment that are mounted on it.The disposable smoke evacuator in question was attached to one of the weaker vacuum lines.A suction/irrigation instrument was attached to the stronger line because of its critical need.The stronger line on the boom typically provides just over 400 mm hg of maximum vacuum pressure while the two weaker lines only provide under 300 mm hg at best.This was insufficient to evacuate most of the excess smoke experienced in the abdominal cavity.During the case, the surgeon complained about the smoke evacuator not working properly.Although the circulating nurse was aware that the vacuum line was weak, decided at some point in troubleshooting the problem that she offered a second smoke evacuator unit.This new unit unfortunately didn't improve upon the surgeon's visibility.The scrub tech and the circulating nurse concluded that the smoke evacuation problem was not due to the disposable smoke evacuator units being defective but was due to the weak vacuum lines on the equipment boom, a re-occurring problem from previous cases in this operating room.Replacement of a new equipment boom and re-piping of the medical gas lines are scheduled to be completed in the near future.

• Brand Name: BERCHTOLD BOOM
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 571 silveron blvd; flower mound TX 75028
• MDR Report Key: 7468180
• MDR Text Key: 106746376
• Report Number: 7468180
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.
• Patient Age: 44 YR