MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ACAIA PEARL SCALE 2.0; SCALE, SPONGE, SURGICAL, ELECTRICALLY-POWERED

Catalog Number	0894-001-015
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the accuracy is off when weighing items.The procedure was completed successfully by weighing the items on another scale.No adverse consequences or medical intervention were reported.

• Brand Name: ACAIA PEARL SCALE 2.0
• Common Device Name: SCALE, SPONGE, SURGICAL, ELECTRICALLY-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 24337641
• Report Number: 3015967359-2026-00105
• Device Sequence Number: 18585173
• Product Code: MRL
• UDI-Device Identifier: 00859506006005
• UDI-Public: (01)00859506006005
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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
• Device Catalogue Number: 0894-001-015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown