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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG UNKNOWN_COMMUNICATION_PRODUCT; LIGHT, SURGICAL, CEILING MOUNTED
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BERCHTOLD GMBH & CO. KG UNKNOWN_COMMUNICATION_PRODUCT; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number UNK_SCC
Device Problem Off-Label Use (1494)
Patient Problem Burn(s) (1757)
Event Date 03/31/2022
Event Type  Injury  
Event Description
It was reported that during thyroid surgery in no.29 operating room the patient's skin under the shadowless lamp was burning.It was further reported the patient was treated with ointment and the burned skin part has turned to normal.
 
Manufacturer Narrative
It was reported that towards the end of a thyroid surgery after suturing had been completed, it was discovered that the patient had sustained a skin burn.It was noted that the temperature emitted from the shadowless lamp was very high, prompting the medical staff to turn the light off and remove it from the surgical site.Contact was made with the strker (b)(4) raqa team and updates were provided.It was confirmed that there were two lights used during the procedure.The exact position of the lights at the time the incident occurred is unknown.Regarding the skin burn, it was noted that the patient sustained slight burns and that the burns were treated with ointment.After treatment, it was reported that that the affected skin returned to normal.There was minimal surgical delay, as the suturing had already been completed at the time the skin burn was discovered.Due to current covid-19 conditions, a stryker field service team member has been unable to go onsite to investigate, and it is unknown when they will be permitted to enter the facility.Although the exact root cause of this issue is unknown, the most likely root cause would improper positioning of the surgical lights due to user error, as outlined in the chromophare e650 surgical lights operations manual, part # (b)(4) revision 1.Page 45 of the manual discusses the risk of tissue necrosis from heating of the surgical field, and states that if the filtering system is defective, multiple light fields overlap, or if the light is too close to the surgical field, the surgical field can overheat.This can cause the tissue to heat up and dry out, and even result in necrosis following excessive exposure.This issue has not exceeded any thresholds and will continue to be monitored per (b)(4).If any further information is obtained, a supplemental will be filed.
 
Event Description
It was reported that during thyroid surgery in no.29 operating room the patient's skin under the shadowless lamp was burning.It was further reported the patient was treated with ointment and the burned skin part has turned to normal.
 
Manufacturer Narrative
[supplemental 001] field h6, results code grid, was updated.
 
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Brand Name
UNKNOWN_COMMUNICATION_PRODUCT
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
BERCHTOLD GMBH & CO. KG
ludwigstaler strasse 25
tuttlingen 78532
GM  78532
Manufacturer (Section G)
BERCHTOLD GMBH & CO. KG
ludwigstaler strasse 25
tuttlingen 78532
GM   78532
Manufacturer Contact
volker hornscheidt
ludwigstaler strasse 25
tuttlingen 78532
GM   78532
74611810
MDR Report Key14355907
MDR Text Key291378096
Report Number0008010153-2022-00008
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberUNK_SCC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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