MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DISP CABLE W/IRR GRAVITY, UNI; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	6790100002
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during preparation for a procedure, foreign material was found in the sterilized product.The procedure was completed successfully using a different device.There was patient involvement, no surgical delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.
Event or Problem Description
The user facility reported that during preparation for a procedure, foreign material was found in the sterilized product.The procedure was completed successfully using a different device.There was patient involvement, no surgical delay, no medical intervention, and no adverse consequences.

• Brand Name: DISP CABLE W/IRR GRAVITY, UNI
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 14268961
• Report Number: 3015967359-2022-00952
• Device Sequence Number: 4840868
• Product Code: GEI
• UDI-Device Identifier: 37613327304252
• UDI-Public: 37613327304252
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2022

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 Catalogue Number: 6790100002
• Device Lot Number: 5986051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown