MAUDE Adverse Event Report: MICROLINE SURGICAL, INC. GRABBER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 3241

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2016

Event Type  malfunction  

Event Description

An extra-long grasper tip was used during robotic laparoscopic bilateral hernia repair case - grasper was hand operated.The black plastic insulation tube on renew laparoscopic instrument reusable tip broke.Part was able to be retrieved and the remaining part (approximately 6 mm x 4 mm) was unable to be found and was left in patient's abdominal cavity.

• Brand Name: GRABBER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MICROLINE SURGICAL, INC.; 50 dunham rd.; beverly MA 01915
• MDR Report Key: 6208505
• MDR Text Key: 63400549
• Report Number: 6208505
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

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 Operator: No Information
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 00T29646
• Other Device ID Number: (01)00811099011675
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR