MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., RESECTOR SHAVER BLADE, F - SERIES - 5.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 0375562000

Device Problems Break (1069); Component Missing (2306)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.

Event Description

It was reported that the device potentially broke inside the patient and was not able to be removed.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: missing part.Probable root cause: inadequate window profile, inadequate welding process (i.E.Plasma, inductive, gluing), improper material strength, inadequate size selected for the application, material brittleness , excessive force applied by the user, incorrect rfid tag.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.

Event Description

It was reported that the device potentially broke inside the patient and was not able to be removed.

• Brand Name: PKG., RESECTOR SHAVER BLADE, F - SERIES - 5.5MM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12870384
• MDR Text Key: 281220206
• Report Number: 0002936485-2021-00675
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 37613327061872
• UDI-Public: 37613327061872
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0375562000
• Device Lot Number: 21137CE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other