MAUDE Adverse Event Report: INPECO SA ACCELERATOR A3600; LABORATORY AUTOMATION SYSTEM

Model Number	ACP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported a field service engineer suffered a injury on (b)(6) 2022 while he was working on the storage and retrieval module.He hurt his left shoulder while he was removing and lifting the srm side cover to gain access to the shelves.The doctor ordered rehab from on (b)(6) 2022 to on (b)(6) 2022.The fse discontinued rehab on (b)(6) 2022 and performed a mri on (b)(6) 2022.The evaluation shows a complete tear off of tendons and large rotator cuff tear.The fse is evaluating possible treatment options suggested by his doctor.
Additional Manufacturer Narrative
The fse was working on the storage and retrieval module (srm) to perform a shelf adjustment.It was not communicated which procedure among the ones reported in the service manual he was following.Reviewing the service manual provided by inpeco the procedures which require the removal and the lift of the srm side cover include the warning: "at least one person on each side of each panel is required to lift up the panels.Use of protection gloves during this operation is mandatory." the fse reported that he performed the operation alone.The service manual has been evaluated complete and correct.No further details about the fse injury and the medical treatment were provided from the field.

• Brand Name: ACCELERATOR A3600
• Common Device Name: LABORATORY AUTOMATION SYSTEM
• Manufacturer (Section D): INPECO SA; via torraccia 26; novazzano 6883 ; SZ 6883
• Manufacturer (Section G): INPECO SPA; via givoletto 15; val della torre, 10040 ; IT 10040
• Manufacturer Contact: eva balzarotti ; via torraccia 26; novazzano, 6883 ; SZ 6883
• MDR Report Key: 16144561
• Report Number: 3010825766-2023-00001
• Device Sequence Number: 6839300
• Product Code: CEM
• UDI-Device Identifier: 07640172341001
• UDI-Public: (01)07640172341001(11)180223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K121012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ACP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/12/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown