MAUDE Adverse Event Report: MAQUET SAS MAQUET STERIGRIP; LIGHT, SURGICAL, ACCESSORIES

Model Number	ARD567203900
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 9th january, 2024 getinge became aware of an issue with one of surgical equipment - maquet sterigrip.It was stated the mounting was broken with missing particles on sterigrip, and as a result there was a risk of detachment of handle.It was confirmed by photographic evidence the screw supports from handle were broken with missing particles.It was found that the likely cause of the problem would be failure to comply with the maximum number of uses/sterilizations recommended by the manufacturer.According to the customer's calculation, the number of times used/sterilized is on average around 104 times, thus far exceeding the recommended amount- according to the ifu 01781 en 18 page 92, the handles have a maximum number of 50 recommended sterilization cycles, with the risk of falling off the support if exceeded.We decided to report the issue in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The correction of d1 brand name, d4 version or model #, d4 catalog #, d4 unique identifier (udi) #, h4 manufacture date, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain deems required.This is based on the internal evaluation.Previous d1 brand name: stg; corrected d1 brand name: maquet sterigrip.Previous d4 version or model # ard567203972; corrected d4 version or model # ard567203900.Previous d4 catalog # ard567203972; corrected d4 catalog # none.Previous d4 unique identifier (udi) #: n/a; corrected d4 unique identifier (udi) #: (b)(4).Previous h3a device evaluated by manufacturer: no; corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other; corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer; corrected h3c if other provide code - explain: n/a.Getinge became aware of an issue with one of surgical equipment - maquet sterigrip.It was stated the mounting was broken with missing particles on sterigrip and as a result there was a risk of detachment of handle.It was confirmed by photographic evidence the screw supports from handle were broken with missing particles.It was found that the likely cause of the problem would be failure to comply with the maximum number of uses/sterilizations recommended by the manufacturer.According to the customer's calculation, the number of times used/sterilized is on average around 104 times, thus far exceeding the recommended amount - according to the ifu 01781 en 18 page 92, the handles have a maximum number of 50 recommended sterilization cycles, with the risk of falling off the support if exceeded.We decided to report the issue in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination or serious injury.Based on the information collected, it was established that when the event occurred, the surgical equipment did not meet its specification and in this way the device contributed to event.The claimed device was not being used for patient treatment or diagnosis when the event took place.The fact that 12 sterilizable handles are involved and have the same breakage (same location) ruled out the possibility of a shock with another device.It was confirmed that the sterilization process used is the one provided by getinge.As well, it was recognized that the number of sterilization cycles exceeded the number of the 50 recommended ones.Indeed, it was around 104 so more than the double.Too many cycles can lead to weaken the material and it becomes brittle.This is the most probable root cause of this breakage.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: MAQUET STERIGRIP
• Common Device Name: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 18550094
• Report Number: 9710055-2024-00057
• Device Sequence Number: 7596806
• Product Code: FTA
• UDI-Device Identifier: 03700712405120
• UDI-Public: (01)03700712405120
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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 Model Number: ARD567203900
• Device Catalogue Number: ARD567203972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown