MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG UNKNOWN_COMMUNICATION_PRODUCT; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number UNK_SCC

Device Problem Output above Specifications (1432)

Patient Problem Burn(s) (1757)

Event Date 11/29/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a 7cm x 7cm second-degree burn was found on a patient¿s abdomen on (b)(6) 2023, during procedure in operating room 3 which required unknown medical intervention.The operating room 3 includes a 4-surgical light configuration.Stryker personnel performed a functional inspection on (b)(6) 2023, at (b)(6) in operating room 3.Stryker determined that lights are working as expected and within the expected range.The exact position of the lights at the time the incident occurred is unknown.Stryker did not find any evidence to support these lights contributed to the reported adverse event and recommend investigating other contributing factors.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 surgical lights operations manual, part#: 57393, revision ya, page 57.The manual discusses the risk of tissue necrosis from heating of the surgical field, and states that if 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 dwi2003.If any further information is obtained, a supplemental will be filed.

Event Description

It was reported that the slx light in operating room 3 burned the patient which required medical intervention.It was a 7cm x 7cm 2nd degree burn on the patient¿s abdomen.

• 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 Key: 18380519
• MDR Text Key: 331176973
• Report Number: 0008010153-2023-00025
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SCC
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other