MAUDE Adverse Event Report: STORZ STORZ; RETRO AGGRESIVE INSECT GRASPER 5MM

Catalog Number 33310 HM

Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923); Device Fell (4014)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/13/2018

Event Type  malfunction  

Event Description

Per operative report on (b)(6) 2018, surgeon noted as part of this procedure on while dissecting free the cord lipoma a stainless steel laparoscopic grasper that had been used, but became defective as a small pin which held the grasper mechanism in place.Became dislodged.This was lost within the peritoneal cavity.This small pin again was a stainless steel instrument and measured approx less than i mm in size.We were unable to locate this.We did obtain a post procedure film of the pelvis and abdomen which showed our nonabsorbable stainless steel tackers in place as well as the small punctate area, which is likely this retained foreign body.

• Brand Name: STORZ
• Type of Device: RETRO AGGRESIVE INSECT GRASPER 5MM
• Manufacturer (Section D): STORZ ; tuttlingen 78532 ; GM 78532
• MDR Report Key: 7894078
• MDR Text Key: 121579496
• Report Number: 7894078
• Device Sequence Number: 1
• Product Code: GCJ
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/12/2018

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 Catalogue Number: 33310 HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2018
• Device Age: 5 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: No Information
• 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: 71 YR
• Patient Weight: 72